INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM


Device Classification Name

system, hypothermia, intravenous, cooling

510(k) Number K080908
Device Name INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
Applicant
INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION
6740 top gun street
san diego, 
CA 
92121

Applicant Contact jennifer spinella
Correspondent
INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION
6740 top gun street
san diego, 
CA 
92121

Correspodent Contact jennifer spinella
Regulation Number 870.5900
Classification Product Code
NCX  
Date Received 04/01/2008
Decision Date 10/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls