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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 K894631
Device Name NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.
Applicant
Nihon Kohden America, Inc.
17112 Armstrong Ave.
Irvine,  CA  92714
Applicant Contact ALEX GERWER
Correspondent
Nihon Kohden America, Inc.
17112 Armstrong Ave.
Irvine,  CA  92714
Correspondent Contact ALEX GERWER
Regulation Number870.2100
Classification Product Code
DPW  
Date Received07/24/1989
Decision Date 01/19/1990
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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