BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM


Device Classification Name

system, thermal regulating

510(k) Number K021473
Device Name BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
Original Applicant
AUGUSTINE MEDICAL, INC.
10393 west 70th st.
eden prairie, 
MN 
55344

Original Contact scott d augustine
Regulation Number 870.5900
Classification Product Code
DWJ  
Date Received 05/08/2002
Decision Date 07/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No