[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR898.13]

[Page 522]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 898--PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES--Table of Contents
 
Sec. 898.13  Compliance dates.

    The dates for compliance with the standard set forth in 
Sec. 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
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                                                             21 CFR
                Phase                    Product code       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.
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    (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.