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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR898.13]
See Related Information on Compliance dates. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 898 -- PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES

Sec. 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:

Listing of Devices for Which Compliance is Required Effective

May 11, 1998

PhaseProduct code21 CFR sectionClassDevice 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.

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