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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 K854267
Device Name HUNTLEIGH DOPCORD, D140
Applicant
Huntleigh Technology, Inc.
227 Rte. 33 E.
Manalapan,  NJ  07726
Applicant Contact JAMES BRITTON
Correspondent
Huntleigh Technology, Inc.
227 Rte. 33 E.
Manalapan,  NJ  07726
Correspondent Contact JAMES BRITTON
Regulation Number884.2660
Classification Product Code
KNG  
Date Received10/23/1985
Decision Date 07/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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