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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 898—PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES > 898.13—Compliance dates.

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:
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 DPS 870.2340 II Electrocardiograph.
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.
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