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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K860435
Device Name MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER
Applicant
Multigon Industries, Inc.
P.O. Box 2485
Mt. Vernon,  NY  10551
Applicant Contact WILLIAM STERN
Correspondent
Multigon Industries, Inc.
P.O. Box 2485
Mt. Vernon,  NY  10551
Correspondent Contact WILLIAM STERN
Regulation Number870.2120
Classification Product Code
DPT  
Date Received02/04/1986
Decision Date 05/05/1986
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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