Device Classification Name |
analyzer, gas, carbon-monoxide, gaseous-phase
|
510(k) Number |
K080278 |
Device Name |
TABATABA COTESTER |
Applicant |
FIM MEDICAL |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
FIM MEDICAL |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 868.1430
|
Classification Product Code |
|
Date Received | 02/04/2008 |
Decision Date | 11/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|