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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 K103801
Device Name HYPOTHERMX INTRAVENOUS FLUID WARMER
Applicant
Emit Corporation
42 N. Chatsong Cir.
Woodlands,  TX  77382
Applicant Contact DARLA J ELKIN
Correspondent
Emit Corporation
42 N. Chatsong Cir.
Woodlands,  TX  77382
Correspondent Contact DARLA J ELKIN
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received12/28/2010
Decision Date 05/20/2011
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
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