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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 K844631
Device Name PERIFLUX PF-2
Applicant
Medex, Inc.
3637 Lacon Rd.
Hilliard,  OH  43026
Applicant Contact MARK T SANDRINI
Correspondent
Medex, Inc.
3637 Lacon Rd.
Hilliard,  OH  43026
Correspondent Contact MARK T SANDRINI
Regulation Number870.2100
Classification Product Code
DPW  
Date Received11/27/1984
Decision Date 02/20/1985
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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