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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 K001882
Device Name BABY DOPPLEX 4002-TWINS, MODEL BD4002
Applicant
HUNTLEIGH HEALTHCARE, INC.
40 CHRISTOPHER WAY
EATONTOWN,  NJ  07724 -3327
Applicant Contact AUDREY A WITKO
Correspondent
HUNTLEIGH HEALTHCARE, INC.
40 CHRISTOPHER WAY
EATONTOWN,  NJ  07724 -3327
Correspondent Contact AUDREY A WITKO
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/21/2000
Decision Date 09/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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