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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR868.2025]
See Related Information on Ultrasonic air embolism monitor. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 868 -- ANESTHESIOLOGY DEVICES

Subpart C--Monitoring Devices

Sec. 868.2025 Ultrasonic air embolism monitor.

(a) Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It may use Doppler or other ultrasonic principles.

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

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