The following data is part of a premarket notification filed by Optical Sensors, Inc. with the FDA for Capnoprobe Sl, Model 2000.
| Device ID | K010795 |
| 510k Number | K010795 |
| Device Name: | CAPNOPROBE SL, MODEL 2000 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | OPTICAL SENSORS, INC. 800 LENANGER LN. Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring OPTICAL SENSORS, INC. 800 LENANGER LN. Stoughton, WI 53589 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-16 |
| Decision Date | 2001-04-11 |