THERMOGARD XP THERMAL REGULATION SYSTEM


Device Classification Name

system, hypothermia, intravenous, cooling

510(k) Number K072234
Device Name THERMOGARD XP THERMAL REGULATION SYSTEM
Applicant
ALSIUS CORP.
15770 laguna canyon rd
suite 150
irvine, 
CA 
92618

Applicant Contact kenneth a collins
Correspondent
ALSIUS CORP.
15770 laguna canyon rd
suite 150
irvine, 
CA 
92618

Correspodent Contact kenneth a collins
Regulation Number 870.5900
Classification Product Code
NCX  
Date Received 08/10/2007
Decision Date 08/23/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No