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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 K943106
Device Name ADULT VENTILATOR
Applicant
INFRASONICS CORP.
3911 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121 -1402
Applicant Contact JIM HITCHIN
Correspondent
INFRASONICS CORP.
3911 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121 -1402
Correspondent Contact JIM HITCHIN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/29/1994
Decision Date 12/28/1995
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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