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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K904117
Device Name SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.
Applicant
Dawn Medical
210 San Benito Way
San Francisco,  CA  94127
Applicant Contact BRUCE FITZGERALD
Correspondent
Dawn Medical
210 San Benito Way
San Francisco,  CA  94127
Correspondent Contact BRUCE FITZGERALD
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/06/1990
Decision Date 02/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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