The following data is part of a premarket notification filed by Optical Sensors, Inc. with the FDA for Olympus Critical Care Monitoring System.
| Device ID | K963935 |
| 510k Number | K963935 |
| Device Name: | OLYMPUS CRITICAL CARE 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 | Denise Schottler |
| Correspondent | Denise Schottler 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 | Yes |
| Date Received | 1996-10-01 |
| Decision Date | 1997-01-23 |
| Summary: | summary |