The following data is part of a premarket notification filed by Optical Sensors, Inc. with the FDA for Capno Probe A.
| Device ID | K984579 |
| 510k Number | K984579 |
| Device Name: | CAPNO PROBE A |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | OPTICAL SENSORS, INC. 7615 GOLDEN TRIANGLE DR., SUITE A Eden Prairie, MN 55344 |
| Contact | Gary J Syring |
| Correspondent | Gary J Syring OPTICAL SENSORS, INC. 7615 GOLDEN TRIANGLE DR., SUITE A Eden Prairie, MN 55344 |
| Product Code | CCK |
| Subsequent Product Code | CBR |
| Subsequent Product Code | KNT |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-23 |
| Decision Date | 2000-12-21 |
| Summary: | summary |