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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 K890828
Device Name PERIFLUX PF3
Applicant
Perimed, Inc.
800 Centennial Ave.
Piscataway,  NJ  08855
Applicant Contact OYSTEIN LIND
Correspondent
Perimed, Inc.
800 Centennial Ave.
Piscataway,  NJ  08855
Correspondent Contact OYSTEIN LIND
Regulation Number870.2100
Classification Product Code
DPW  
Date Received02/21/1989
Decision Date 06/20/1989
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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