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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, ultrasonic, fetal
510(k) Number K013547
Device Name BABYCOM
Applicant
PMG MEDICA LTD.
POB 6718
EFRAT,  IL 90435
Applicant Contact ELI M ORBACH
Correspondent
PMG MEDICA LTD.
POB 6718
EFRAT,  IL 90435
Correspondent Contact ELI M ORBACH
Regulation Number884.2660
Classification Product Code
KNG  
Date Received10/24/2001
Decision Date 02/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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