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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K853487
Device Name PATIENT BREATHING CIRCUIT
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 Number868.5905
Classification Product Code
BZD  
Date Received08/20/1985
Decision Date 09/06/1985
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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