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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K021574
Device Name TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
Applicant
Card Guard Scientific Survival , Ltd.
2 Pekeris St.
P.O. Box 527
Rehovot,  IL 76100
Applicant Contact ALEX GONOROVSKY
Correspondent
Card Guard Scientific Survival , Ltd.
2 Pekeris St.
P.O. Box 527
Rehovot,  IL 76100
Correspondent Contact ALEX GONOROVSKY
Regulation Number884.2740
Classification Product Code
HGM  
Date Received05/14/2002
Decision Date 08/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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