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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K024300
Device Name MICROCAP PLUS/NPB-75
Applicant
Oridion Medical 1987 , Ltd.
7 Hamarpe St. P.O. Box 45025
Har Hotzvim Industrial Park
Jerusalem,  IL 91450
Applicant Contact SANDY BROWN
Correspondent
Oridion Medical 1987 , Ltd.
7 Hamarpe St. P.O. Box 45025
Har Hotzvim Industrial Park
Jerusalem,  IL 91450
Correspondent Contact SANDY BROWN
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
CCK  
Date Received12/24/2002
Decision Date 04/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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