Capnomask
510(k) K131339
Capnomask is a medical device (FDA Class II; FDA product code CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) made by Mediplus, Ltd., cleared under FDA 510(k) K131339 on 25 Nov 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131339 | Date25 Nov 2013 | StatusActive |
Official records
- FDA 510(k) database K131339
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CCK
- FDA applicant
- Mediplus , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.1400
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K131339
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Mediplus A202Ac | A202Ac | 05055140702807 | — | On the market |
| Mediplus A202Ax-D-M | A202Ax-D-M | 05055140704030 | — | On the market |
| Mediplus A202Ax-M | A202Ax-M | 05055140704009 | — | On the market |
| Mediplus A202CFX | A202CFX | 05055140703859 | — | On the market |
| Mediplus A202CFX-D | A202CFX-D | 05055140703941 | — | On the market |
| Mediplus A202CMX | A202CMX | 05055140700193 | — | On the market |
| Mediplus A202CMX-D | A202CMX-D | 05055140703880 | — | On the market |
| Mediplus A202Cx-D-M | A202Cx-D-M | 05055140704047 | — | On the market |
| Mediplus A202Cx-M | A202Cx-M | 05055140704016 | — | On the market |
| Mediplus A202FX | A202FX | 05055140700834 | — | On the market |
| Mediplus A202FX-D | A202FX-D | 05055140703897 | — | On the market |
| Mediplus A202MX | A202MX | 05055140700872 | — | On the market |
| Mediplus A202MX-D | A202MX-D | 05055140703910 | — | On the market |
| Mediplus A202PFX | A202PFX | 05055140703842 | — | On the market |
| Mediplus A202PFX-D | A202PFX-D | 05055140703934 | — | On the market |
| Mediplus A202PMX | A202PMX | 05055140701725 | — | On the market |
| Mediplus A202PMX-D | A202PMX-D | 05055140703927 | — | On the market |
| Mediplus A202Px-D-M | A202Px-D-M | 05055140704054 | — | On the market |
| Mediplus A202Px-M | A202Px-M | 05055140704023 | — | On the market |
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Other devices filed under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase).
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- CARBON DIOXIDE MONITOR, MODEL OLG-2800A by NIHON KOHDEN AMERICA, INC.
- BIOCHEM 8800 CAPNOMETER by Biochem International, Inc.