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.