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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 K860798
Device Name ARF-1500 CONTINUOUS VENTILATOR
Applicant
Medimex, Inc.
300 Hempstead Tpke.
West Hempstead,  NY  11552
Applicant Contact WALTER LEDER
Correspondent
Medimex, Inc.
300 Hempstead Tpke.
West Hempstead,  NY  11552
Correspondent Contact WALTER LEDER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/04/1986
Decision Date 07/10/1986
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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