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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 K900618
Device Name HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140
Applicant
HUNTLEIGH TECHNOLOGY, INC.
227 ROUTE 33 EAST
MANALAPAN,  NJ  07726
Applicant Contact JAMES BRITTON
Correspondent
HUNTLEIGH TECHNOLOGY, INC.
227 ROUTE 33 EAST
MANALAPAN,  NJ  07726
Correspondent Contact JAMES BRITTON
Regulation Number884.2660
Classification Product Code
KNG  
Date Received02/08/1990
Decision Date 04/25/1990
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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