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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mixer, breathing gases, anesthesia inhalation
510(k) Number K952878
Device Name OXY/STAR LOW FLOW BLENDER
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 Number868.5330
Classification Product Code
BZR  
Date Received06/23/1995
Decision Date 09/25/1995
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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