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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K761025
Device Name BAG RESUSCITATOR
Applicant
ROBERT SHAW CONTROLS CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ROBERT SHAW CONTROLS CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5915
Classification Product Code
BTM  
Date Received11/12/1976
Decision Date 11/24/1976
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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