The following data is part of a premarket notification filed by Seebreath Ab with the FDA for Capnodura Combi & Capnodura Pedi Co2 Detector.
| Device ID | K112840 |
| 510k Number | K112840 |
| Device Name: | CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | SEEBREATH AB MORKULLEVAGEN 31 Bjarred, SE 23736 |
| Contact | Anette Sjogren |
| Correspondent | Anette Sjogren SEEBREATH AB MORKULLEVAGEN 31 Bjarred, SE 23736 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-29 |
| Decision Date | 2012-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50190752158427 | K112840 | 000 |