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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 K922477
Device Name MODEL 105 VENTILATOR, 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 Received05/27/1992
Decision Date 08/24/1992
Decision Substantially Equivalent (SESE)
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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