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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K862720
Device Name VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES
Applicant
Sonicaid, Inc.
P.O. Box 588
Fredericksburg,  VA  22401
Applicant Contact ROBERT WAXHAM
Correspondent
Sonicaid, Inc.
P.O. Box 588
Fredericksburg,  VA  22401
Correspondent Contact ROBERT WAXHAM
Regulation Number870.2100
Classification Product Code
DPW  
Date Received07/17/1986
Decision Date 11/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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