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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
Predetermined Change
Control Plan Authorized		 No
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