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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
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