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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 K853952
Device Name METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME
Applicant
Metriflow, Inc.
8702 Watertown Plank Rd.
Milwaukee,  WI  53226
Applicant Contact GALE E DAVIS
Correspondent
Metriflow, Inc.
8702 Watertown Plank Rd.
Milwaukee,  WI  53226
Correspondent Contact GALE E DAVIS
Regulation Number870.2100
Classification Product Code
DPW  
Date Received09/25/1985
Decision Date 01/05/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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