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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K911804
Device Name INFRASONICS VENTILATOR ADULT STAR, MODIFICATION
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 Number868.5895
Classification Product Code
CBK  
Date Received04/24/1991
Decision Date 06/11/1992
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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