The following data is part of a premarket notification filed by Optical Sensors, Inc. with the FDA for Point-of-care Arterial Blood Gas Monitoring System.
Device ID | K951094 |
510k Number | K951094 |
Device Name: | POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING 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 | Gary Syring |
Correspondent | Gary Syring OPTICAL SENSORS, INC. 7615 GOLDEN TRIANGLE DR., SUITE A Eden Prairie, MN 55344 |
Product Code | CCC |
CFR Regulation Number | 868.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-09 |
Decision Date | 1996-01-16 |