Is this your brand? Sign in to claim ownership.
Sign in to claim this brandCapnia, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1101 Chess Drive, Foster City, CA, 94404
- Website
- capnia.com
- —
- —
- [email protected]
- Phone
- 6502138444
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3008614998
- DUNS Number
- 030593896
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CoSense ETCO Monitor | C20112 | FDA UDI | Class II | Active |
| CoSense ETCO Monitor | K151107 | FDA 510(k) | Class II | Active |
| Cosense | K121768 | FDA 510(k) | Class II | Active |
| Cosense Co Monitor | K130036 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 21, 2025 | Z-2198-2025 | — | open, classified | Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations. |