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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaporizer, Anesthesia, Non-Heated
510(k) Number K854202
Device Name ANESTHESIA VENTILATOR MODEL 100
Applicant
Rusz Instruments, Inc.
17 Keeler St.
Pittsfield,  MA  01201
Applicant Contact TIBOR RUSZ
Correspondent
Rusz Instruments, Inc.
17 Keeler St.
Pittsfield,  MA  01201
Correspondent Contact TIBOR RUSZ
Regulation Number868.5880
Classification Product Code
CAD  
Date Received10/15/1985
Decision Date 04/11/1986
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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