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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Heart Rate, Fetal, Ultrasonic
510(k) Number K003876
Device Name US SENSOR #CG-930P; TOCO SENSOR CG-940P
Applicant
Card Guard Scientific Survival , Ltd.
2 Pekeris St.
Rehovot,  IL 76100
Applicant Contact ALEX GONOROVSKY
Correspondent
Card Guard Scientific Survival , Ltd.
2 Pekeris St.
Rehovot,  IL 76100
Correspondent Contact ALEX GONOROVSKY
Regulation Number884.2660
Classification Product Code
HEL  
Subsequent Product Code
HFM  
Date Received12/15/2000
Decision Date 07/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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