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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 K974285
Device Name PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
Applicant
Perimed, Inc.
821 W. Jericho Tpke.
Suite A
Smithtown,  NY  11787
Applicant Contact KJELL BAKKEN
Correspondent
Perimed, Inc.
821 W. Jericho Tpke.
Suite A
Smithtown,  NY  11787
Correspondent Contact KJELL BAKKEN
Regulation Number870.2100
Classification Product Code
DPW  
Date Received11/14/1997
Decision Date 05/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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