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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
Applicant Contact ANDY WOOD
Correspondent
Huntleigh Healthcare, Inc.
40 Christopher Way
Eatontown,  NJ  07724
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
Predetermined Change
Control Plan Authorized		 No
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