21 CFR § 898.13 - Compliance dates.

---
identifier: "/us/cfr/t21/s898.13"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 898.13 - Compliance dates."
title_number: 21
title_name: "Food and Drugs"
section_number: "898.13"
section_name: "Compliance dates."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "898"
part_name: "PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371, 374; 42 U.S.C. 262, 264."
regulatory_source: "62 FR 25497, May 9, 1997, unless otherwise noted."
cfr_part: "898"
---


# 898.13 Compliance dates.

The dates for compliance with the standard set forth in § 898.12(a) shall be as follows:

(a) For electrode lead wires and patient cables used with, or intended for use with, the following devices, the date for which compliance is required is May 11, 1998:

Listing of Devices for Which Compliance is Required Effective

May 11, 1998

| Phase | Product code | 21 CFR section | Class | Device name |
| --- | --- | --- | --- | --- |
| 1 | 73 BZQ | 868.2375 | II | Monitor, Breathing Frequency. |
| 1 | 73 FLS | 868.2375 | II | Monitor (Apnea Detector), Ventilatory Effort. |
| 1 | 74 DPS | 870.2340 | II | Electrocardiograph. |
| 1 | 74 DRG | 870.2910 | II | Transmitters and Receivers, Physiological Signal, Radio Frequency. |
| 1 | 74 DRT | 870.2300 | II | Monitor, Cardiac (including Cardiotachometer and Rate Alarm). |
| 1 | 74 DRX | 870.2360 | II | Electrode, Electrocardiograph. |
| 1 | 74 DSA | 870.2900 | II | Cable, Transducer and Electrode, Patient (including Connector). |
| 1 | 74 DSH | 870.2800 | II | Recorder, Magnetic Tape, Medical. |
| 1 | 74 DSI | 870.1025 | III | Detector and Alarm, Arrhythmia. |
| 1 | 74 DXH | 870.2920 | II | Transmitters and Receivers, Electrocardiograph, Telephone. |

(b) For electrode lead wires and patient cables used with, or intended for use with, any other device, the date for which compliance is required is May 9, 2000.