Title 21, Part 868 — Anesthesiology Devices
150 sections
Section 868.1
Scope.
Section 868.3
Effective dates of requirement for premarket approval.
Section 868.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Section 868.1030
Manual algesimeter.
Section 868.1040
Powered algesimeter.
Section 868.1075
Argon gas analyzer.
Section 868.1100
Arterial blood sampling kit.
Section 868.1120
Indwelling blood oxyhemoglobin concentration analyzer.
Section 868.1150
Indwelling blood carbon dioxide partial pressure (P) analyzer.
Section 868.1170
Indwelling blood hydrogen ion concentration (pH) analyzer.
Section 868.1200
Indwelling blood oxygen partial pressure (P) analyzer.
Section 868.1400
Carbon dioxide gas analyzer.
Section 868.1430
Carbon monoxide gas analyzer.
Section 868.1500
Enflurane gas analyzer.
Section 868.1505
Ventilatory electrical impedance tomograph.
Section 868.1575
Gas collection vessel.
Section 868.1620
Halothane gas analyzer.
Section 868.1640
Helium gas analyzer.
Section 868.1670
Neon gas analyzer.
Section 868.1690
Nitrogen gas analyzer.
Section 868.1700
Nitrous oxide gas analyzer.
Section 868.1720
Oxygen gas analyzer.
Section 868.1730
Oxygen uptake computer.
Section 868.1750
Pressure plethysmograph.
Section 868.1760
Volume plethysmograph.
Section 868.1780
Inspiratory airway pressure meter.
Section 868.1800
Rhinoanemometer.
Section 868.1840
Diagnostic spirometer.
Section 868.1850
Monitoring spirometer.
Section 868.1860
Peak-flow meter for spirometry.
Section 868.1870
Gas volume calibrator.
Section 868.1880
Pulmonary-function data calculator.
Section 868.1890
Predictive pulmonary-function value calculator.
Section 868.1900
Diagnostic pulmonary-function interpretation calculator.
Section 868.1910
Esophageal stethoscope.
Section 868.1920
Esophageal stethoscope with electrical conductors.
Section 868.1930
Stethoscope head.
Section 868.1965
Switching valve (ploss).
Section 868.1975
Water vapor analyzer.
Section 868.2025
Ultrasonic air embolism monitor.
Section 868.2300
Bourdon gauge flowmeter.
Section 868.2320
Uncompensated thorpe tube flowmeter.
Section 868.2340
Compensated thorpe tube flowmeter.
Section 868.2350
Gas calibration flowmeter.
Section 868.2375
Breathing frequency monitor.
Section 868.2377
Apnea monitor.
Section 868.2380
Nitric oxide analyzer.
Section 868.2385
Nitrogen dioxide analyzer.
Section 868.2450
Lung water monitor.
Section 868.2480
Cutaneous carbon dioxide (PcCO2) monitor.
Section 868.2500
Cutaneous oxygen (PcO2) monitor.
Section 868.2550
Pneumotachometer.
Section 868.2600
Airway pressure monitor.
Section 868.2610
Gas pressure gauge.
Section 868.2620
Gas pressure calibrator.
Section 868.2700
Pressure regulator.
Section 868.2775
Electrical peripheral nerve stimulator.
Section 868.2875
Differential pressure transducer.
Section 868.2885
Gas flow transducer.
Section 868.2900
Gas pressure transducer.
Section 868.5090
Emergency airway needle.
Section 868.5095
Retrograde intubation device.
Section 868.5100
Nasopharyngeal airway.
Section 868.5105
External negative pressure airway aid.
Section 868.5110
Oropharyngeal airway.
Section 868.5115
Device to relieve acute upper airway obstruction.
Section 868.5120
Anesthesia conduction catheter.
Section 868.5130
Anesthesia conduction filter.
Section 868.5140
Anesthesia conduction kit.
Section 868.5150
Anesthesia conduction needle.
Section 868.5160
Gas machine for anesthesia or analgesia.
Section 868.5165
Nitric oxide administration apparatus.
Section 868.5170
Laryngotracheal topical anesthesia applicator.
Section 868.5180
Rocking bed.
Section 868.5220
Blow bottle.
Section 868.5240
Anesthesia breathing circuit.
Section 868.5250
Breathing circuit circulator.
Section 868.5260
Breathing circuit bacterial filter.
Section 868.5270
Breathing system heater.
Section 868.5273
Positive airway pressure delivery system.
Section 868.5280
Breathing tube support.
Section 868.5300
Carbon dioxide absorbent.
Section 868.5310
Carbon dioxide absorber.
Section 868.5320
Reservoir bag.
Section 868.5330
Breathing gas mixer.
Section 868.5340
Nasal oxygen cannula.
Section 868.5350
Nasal oxygen catheter.
Section 868.5365
Posture chair for cardiac or pulmonary treatment.
Section 868.5375
Heat and moisture condenser (artificial nose).
Section 868.5400
Electroanesthesia apparatus.
Section 868.5420
Ether hook.
Section 868.5430
Gas-scavenging apparatus.
Section 868.5440
Portable oxygen generator.
Section 868.5450
Respiratory gas humidifier.
Section 868.5454
High flow humidified oxygen delivery device.
Section 868.5460
Therapeutic humidifier for home use.
Section 868.5470
Hyperbaric chamber.
Section 868.5480
Isocapnic ventilation device.
Section 868.5530
Flexible laryngoscope.
Section 868.5540
Rigid laryngoscope.
Section 868.5550
Anesthetic gas mask.
Section 868.5560
Gas mask head strap.
Section 868.5570
Nonrebreathing mask.
Section 868.5580
Oxygen mask.
Section 868.5590
Scavenging mask.
Section 868.5600
Venturi mask.
Section 868.5620
Breathing mouthpiece.
Section 868.5630
Nebulizer.
Section 868.5640
Medicinal nonventilatory nebulizer (atomizer).
Section 868.5650
Esophageal obturator.
Section 868.5655
Portable liquid oxygen unit.
Section 868.5665
Powered percussor.
Section 868.5675
Rebreathing device.
Section 868.5690
Incentive spirometer.
Section 868.5700
Nonpowered oxygen tent.
Section 868.5710
Electrically powered oxygen tent.
Section 868.5720
Bronchial tube.
Section 868.5730
Tracheal tube.
Section 868.5740
Tracheal/bronchial differential ventilation tube.
Section 868.5750
Inflatable tracheal tube cuff.
Section 868.5760
Cuff spreader.
Section 868.5770
Tracheal tube fixation device.
Section 868.5780
Tube introduction forceps.
Section 868.5790
Tracheal tube stylet.
Section 868.5795
Tracheal tube cleaning brush.
Section 868.5800
Tracheostomy tube and tube cuff.
Section 868.5810
Airway connector.
Section 868.5820
Dental protector.
Section 868.5830
Autotransfusion apparatus.
Section 868.5860
Pressure tubing and accessories.
Section 868.5870
Nonrebreathing valve.
Section 868.5880
Anesthetic vaporizer.
Section 868.5895
Continuous ventilator.
Section 868.5905
Noncontinuous ventilator (IPPB).
Section 868.5915
Manual emergency ventilator.
Section 868.5925
Powered emergency ventilator.
Section 868.5935
External negative pressure ventilator.
Section 868.5955
Intermittent mandatory ventilation attachment.
Section 868.5965
Positive end expiratory pressure breathing attachment.
Section 868.5975
Ventilator tubing.
Section 868.5995
Tee drain (water trap).
Section 868.6100
Anesthetic cabinet, table, or tray.
Section 868.6175
Cardiopulmonary emergency cart.
Section 868.6225
Nose clip.
Section 868.6250
Portable air compressor.
Section 868.6400
Calibration gas.
Section 868.6700
Anesthesia stool.
Section 868.6810
Tracheobronchial suction catheter.
Section 868.6820
Patient position support.
Section 868.6885
Medical gas yoke assembly.