§ 898.13. Compliance dates.
150 words·~1 min read·
/us/cfr/t21/s§ 898.13·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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 173 BZQ868.2375IIMonitor, Breathing Frequency. 173 FLS868.2375IIMonitor (Apnea Detector), Ventilatory Effort. 174 DPS870.2340IIElectrocardiograph. 174 DRG870.2910IITransmitters and Receivers, Physiological Signal, Radio Frequency. 174 DRT870.2300IIMonitor, Cardiac (including Cardiotachometer and Rate Alarm). 174 DRX870.2360IIElectrode, Electrocardiograph. 174 DSA870.2900IICable, Transducer and Electrode, Patient (including Connector). 174 DSH870.2800IIRecorder, Magnetic Tape, Medical. 174 DSI870.1025IIIDetector and Alarm, Arrhythmia. 174 DXH870.2920IITransmitters 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.