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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 K896613
Device Name FLAT VASCULAR PROBE
Applicant
Imex Medical Systems, Inc.
6355 Joyce Dr.
Golden,  CO  80403
Applicant Contact ED BISTRICK
Correspondent
Imex Medical Systems, Inc.
6355 Joyce Dr.
Golden,  CO  80403
Correspondent Contact ED BISTRICK
Regulation Number870.2100
Classification Product Code
DPW  
Date Received11/21/1989
Decision Date 02/16/1990
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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