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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, Nonfetal
510(k) Number K843933
Device Name VINGMED DS100 DOPPLER FLOWMETER
Applicant
Vingmed, Inc.
P.O. Box 369
Ramsey,  NJ  07446
Applicant Contact GERALD A RICHARDSON
Correspondent
Vingmed, Inc.
P.O. Box 369
Ramsey,  NJ  07446
Correspondent Contact GERALD A RICHARDSON
Regulation Number892.1540
Classification Product Code
JAF  
Date Received10/05/1984
Decision Date 02/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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