21 C.F.R. § 898.13
Compliance dates.
Cite as 21 C.F.R. § 898.13 (2026)
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.
- Cross-references to the CFR
- 898.12