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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 K932068
Device Name PERITEMP PF 4005 HEATER
Applicant
Perimed, Inc.
200 Centennial Ave.
Piscataway,  NJ  08854
Applicant Contact OYSTEIN LIND
Correspondent
Perimed, Inc.
200 Centennial Ave.
Piscataway,  NJ  08854
Correspondent Contact OYSTEIN LIND
Regulation Number870.2100
Classification Product Code
DPW  
Date Received04/29/1993
Decision Date 12/07/1993
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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