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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 K963711
Device Name BABY DOPPLEX (3000)
Applicant
Huntleigh Healthcare, Inc.
227 Rt. 33 E.
Manalapan,  NJ  07726
Applicant Contact AUDREY WITKO
Correspondent
Huntleigh Healthcare, Inc.
227 Rt. 33 E.
Manalapan,  NJ  07726
Correspondent Contact AUDREY WITKO
Regulation Number884.2740
Classification Product Code
HGM  
Date Received09/16/1996
Decision Date 09/12/1997
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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