§ 898.13 Compliance dates.
Primary source
Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
Full Text
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:
(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.
Listing of Devices for Which Compliance is Required EffectiveMay 11, 1998PhaseProduct code21 CFR sectionClassDevice name 173 BZQ868.2375IIMonitor, Breathing Frequency. 173 FLS868.2375IIMonitor (Apnea Detector), Ventilatory Effort. 174 DPS870.234IIElectrocardiograph. 174 DRG870.291IITransmitters and Receivers, Physiological Signal, Radio Frequency. 174 DRT870.23IIMonitor, Cardiac (including Cardiotachometer and Rate Alarm). 174 DRX870.236IIElectrode, Electrocardiograph. 174 DSA870.29IICable, Transducer and Electrode, Patient (including Connector). 174 DSH870.28IIRecorder, Magnetic Tape, Medical. 174 DSI870.1025IIIDetector and Alarm, Arrhythmia. 174 DXH870.292IITransmitters and Receivers, Electrocardiograph, Telephone.
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