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Electronic Code of Federal Regulations

e-CFR data is current as of February 19, 2020

Title 21Chapter ISubchapter HPart 870Subpart D → §870.3630


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart D—Cardiovascular Prosthetic Devices


§870.3630   Pacemaker generator function analyzer.

(a) Identification. A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.

(b) Classification. Class II (performance standards).

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