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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K920954
Device Name AIR STAR
Applicant
INFRASONICS CORP.
9944 BARNES CANYON RD.
SAN DIEGO,  CA  92121
Applicant Contact JIM HITCHIN
Correspondent
INFRASONICS CORP.
9944 BARNES CANYON RD.
SAN DIEGO,  CA  92121
Correspondent Contact JIM HITCHIN
Regulation Number868.6250
Classification Product Code
BTI  
Date Received02/26/1992
Decision Date 08/03/1992
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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