Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
More FDA Info for this Device |
510(K) Number |
K963935 |
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 |
DENISE SCHOTTLER
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 |
10/01/1996 |
Decision Date |
01/23/1997 |
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 |
|