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
|
|
Correspondent Contact |
JENNIFER SPINELLA |
Regulation Number | 870.5900
|
Classification Product Code |
|
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
|
|
|