| Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
More FDA Info for this Device |
| 510(K) Number |
K951094 |
| Device Name |
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling |
| Applicant |
OPTICAL SENSORS, INC.
7615 GOLDEN TRIANGLE DR.,
SUITE A
EDEN PRAIRIE, MN 55344 US
Other 510(k) Applications for this Company
|
| Contact |
Gary Syring
Other 510(k) Applications for this Contact |
| Regulation Number |
868.1150
More FDA Info for this Regulation Number |
| Classification Product Code |
CCC
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
03/09/1995 |
| Decision Date |
01/16/1996 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
AN - Anesthesiology |
| Review Advisory Committee |
AN - Anesthesiology |
| Statement / Summary / Purged Status |
Summary |
| Type |
Traditional |
| Reviewed By Third Party |
N |
| Expedited Review |
|