CELSIUS CONTROL SYSTEM


Device Classification Name

system, hypothermia, intravenous, cooling

510(k) Number K022366
Device Name CELSIUS CONTROL SYSTEM
Original Applicant
INNERCOOL THERAPIES
3931 sorrento valley blvd.
san diego,, 
CA 
92121

Original Contact steve reitzler
Regulation Number 870.5900
Classification Product Code
NCX  
Date Received 07/22/2002
Decision Date 01/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No