The following data is part of a premarket notification filed by Capnia, Inc. with the FDA for Cosense Co Monitor.
| Device ID | K130036 |
| 510k Number | K130036 |
| Device Name: | COSENSE CO MONITOR |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | Capnia, Inc. 2445 FABER PLACE, STUITE 250 Palo Alto, CA 94303 |
| Contact | Julie Blacklock |
| Correspondent | Julie Blacklock Capnia, Inc. 2445 FABER PLACE, STUITE 250 Palo Alto, CA 94303 |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-07 |
| Decision Date | 2014-01-14 |
| Summary: | summary |