HYPOTHERMX INTRAVENOUS FLUID WARMER


Device Classification Name

warmer, thermal, infusion fluid

510(k) Number K103801
Device Name HYPOTHERMX INTRAVENOUS FLUID WARMER
Applicant
EMIT CORPORATION
42 north chatsong circle
woodlands, 
TX 
77382

Applicant Contact darla j elkin
Correspondent
EMIT CORPORATION
42 north chatsong circle
woodlands, 
TX 
77382

Correspodent Contact darla j elkin
Classification Product Code
LGZ  
Date Received 12/28/2010
Decision Date 05/20/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No