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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 K043162
Device Name PMP4 OXY PRO
Applicant
Card Guard Scientific Survival , Ltd.
2 Pekeris St.
P.O. Box 527
Rehovot,  IL 76100
Applicant Contact BORIS ARADOVSKY
Correspondent
Card Guard Scientific Survival , Ltd.
2 Pekeris St.
P.O. Box 527
Rehovot,  IL 76100
Correspondent Contact BORIS ARADOVSKY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/16/2004
Decision Date 12/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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