21 CFR 898.13 – Compliance dates
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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.