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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name attachment, breathing, positive end expiratory pressure
510(k) Number K851194
Device Name AMBU CPAP SYSTEM
Applicant
AMBU, INC.
7 OLD SHERMAN TURNPIKE
DANBURY,  CT  06810
Applicant Contact FRANK HOMA
Correspondent
AMBU, INC.
7 OLD SHERMAN TURNPIKE
DANBURY,  CT  06810
Correspondent Contact FRANK HOMA
Regulation Number868.5965
Classification Product Code
BYE  
Date Received03/26/1985
Decision Date 04/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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