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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 K912234
Device Name SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION
Applicant
SOMNITEC, INC.
7732 BURNET AVE.
VAN NUYS,  CA  91405
Applicant Contact MARK S LONDON
Correspondent
SOMNITEC, INC.
7732 BURNET AVE.
VAN NUYS,  CA  91405
Correspondent Contact MARK S LONDON
Regulation Number868.1840
Classification Product Code
BZG  
Date Received05/17/1991
Decision Date 07/22/1991
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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