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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 K930200
Device Name MULTI DOPPLEX II / FETAL DOPPLEX II
Applicant
HUNTLEIGH HEALTHCARE, INC.
40 CHRISTOPHER WAY
EATONTOWN,  NJ  07724 -3327
Applicant Contact ANDY WOOD
Correspondent
HUNTLEIGH HEALTHCARE, INC.
40 CHRISTOPHER WAY
EATONTOWN,  NJ  07724 -3327
Correspondent Contact ANDY WOOD
Regulation Number884.2660
Classification Product Code
KNG  
Date Received01/14/1993
Decision Date 06/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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