Device Classification Name |
System, Hypothermia, Intravenous, Cooling
|
510(k) Number |
K033623 |
Device Name |
CELSIUS CONTROL SYSTEM |
Applicant |
INNERCOOL THERAPIES, INC. |
3931 SORRENTO VALLEY BLVD. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
STEVE REITZLER |
Correspondent |
INNERCOOL THERAPIES, INC. |
3931 SORRENTO VALLEY BLVD. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
STEVE REITZLER |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 11/18/2003 |
Decision Date | 05/21/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|