The following data is part of a premarket notification filed by Capnia Inc with the FDA for Cosense Etco Monitor.
| Device ID | K151107 |
| 510k Number | K151107 |
| Device Name: | CoSense ETCO Monitor |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | Capnia Inc 3 TWIN DOLPHIN DRIVE SUITE 160 Redwood City, CA 04065 |
| Contact | Kristen Yen |
| Correspondent | Kristen Yen Capnia Inc 3 TWIN DOLPHIN DRIVE SUITE 160 Redwood City, CA 04065 |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-27 |
| Decision Date | 2015-07-22 |
| Summary: | summary |