CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR898.13]

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

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.