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21 C.F.R. § 870.2860   Heart sound transducer.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart C—Cardiovascular Monitoring Devices

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§ 870.2860   Heart sound transducer.

(a) Identification. A heart sound transducer is an external transducer that exhibits a change in mechanical or electrical properties in relation to sounds produced by the heart. This device may be used in conjunction with a phonocardiograph to record heart sounds.

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

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