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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K102900
Device Name HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
Applicant
Hei, Inc.
4801 N. 63rd. St.
Boulder,  CO  80301
Applicant Contact GREGORY MATHISON
Correspondent
Hei, Inc.
4801 N. 63rd. St.
Boulder,  CO  80301
Correspondent Contact GREGORY MATHISON
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received09/30/2010
Decision Date 03/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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