21 CFR 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:
|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.|
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.