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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 K030466
Device Name HANDYDOP
Applicant
ELCAT, GMBH
1308 MORNINGSIDE PARK DR.
ALPHARETTA,  GA  30022
Applicant Contact JAY MANSOUR
Correspondent
ELCAT, GMBH
1308 MORNINGSIDE PARK DR.
ALPHARETTA,  GA  30022
Correspondent Contact JAY MANSOUR
Regulation Number884.2660
Classification Product Code
KNG  
Date Received02/12/2003
Decision Date 09/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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