Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
More FDA Info for this Device |
510(K) Number |
K972314 |
Device Name |
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling |
Applicant |
DIAMETRICS MEDICAL, LTD.
SHORT STREET
HIGH WYCOMBE, BUCKINGHAMSHIRE HP11 2QH GB
Other 510(k) Applications for this Company
|
Contact |
KARIMA HEBRI
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 |
06/20/1997 |
Decision Date |
12/19/1997 |
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 |
|