FDA 510(k) Application Details - K780703

Device Classification Name Monitor, Air Embolism, Ultrasonic

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510(K) Number K780703
Device Name Monitor, Air Embolism, Ultrasonic
Applicant OMP LABORATORIES, INC.

, US
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Regulation Number 868.2025

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Classification Product Code CBA
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Date Received 04/25/1978
Decision Date 07/17/1978
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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