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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 K990569
Device Name BABY DOPPLEX 4000, MODEL BD 4000
Applicant
HUNTLEIGH HEALTHCARE, INC.
227 RT. 33 EAST
MANALAPAN,  NJ  07726
Applicant Contact AUDREY A WITCO
Correspondent
HUNTLEIGH HEALTHCARE, INC.
227 RT. 33 EAST
MANALAPAN,  NJ  07726
Correspondent Contact AUDREY A WITCO
Regulation Number884.2740
Classification Product Code
HGM  
Date Received02/23/1999
Decision Date 01/24/2000
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
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