21 CFR 898.13 - Compliance dates.
(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 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.