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Current as of October 02, 2022 | Updated by FindLaw Staff
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.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.898.13 Compliance dates - last updated October 02, 2022 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-898-13/
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