e-CFR banner

Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

 

Electronic Code of Federal Regulations

e-CFR data is current as of February 27, 2020

Title 21Chapter ISubchapter HPart 898 → §898.13


Title 21: Food and Drugs
PART 898—PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES


§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

PhaseProduct code21 CFR sectionClassDevice name
173 BZQ868.2375IIMonitor, Breathing Frequency.
173 FLS868.2375IIMonitor (Apnea Detector), Ventilatory Effort.
174 DPS870.2340IIElectrocardiograph.
174 DRG870.2910IITransmitters and Receivers, Physiological Signal, Radio Frequency.
174 DRT870.2300IIMonitor, Cardiac (including Cardiotachometer and Rate Alarm).
174 DRX870.2360IIElectrode, Electrocardiograph.
174 DSA870.2900IICable, Transducer and Electrode, Patient (including Connector).
174 DSH870.2800IIRecorder, Magnetic Tape, Medical.
174 DSI870.1025IIIDetector and Alarm, Arrhythmia.
174 DXH870.2920IITransmitters 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.

Need assistance?