The following data is part of a premarket notification filed by Optical Sensors, Inc. with the FDA for Point-of-care Blood Gas Monitor System.
Device ID | K961790 |
510k Number | K961790 |
Device Name: | POINT-OF-CARE BLOOD GAS MONITOR SYSTEM |
Classification | Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling |
Applicant | OPTICAL SENSORS, INC. 7615 GOLDEN TRIANGLE DR., SUITE A Eden Prairie, MN 55344 |
Contact | Denise A Sschottler |
Correspondent | Denise A Sschottler OPTICAL SENSORS, INC. 7615 GOLDEN TRIANGLE DR., SUITE A Eden Prairie, MN 55344 |
Product Code | CCC |
Subsequent Product Code | CBZ |
Subsequent Product Code | CCE |
CFR Regulation Number | 868.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-09 |
Decision Date | 1997-04-09 |
Summary: | summary |