ToxCO
510(k) K173238
ToxCO is a Class II device made by Bedfont Scientific Ltd, cleared under FDA 510(k) K173238 on 4 Apr 2019, 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 | NumberK173238 | Date4 Apr 2019 | StatusActive |
Official records
- FDA 510(k) database K173238
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CCJ
- FDA applicant
- Bedfont Scientific, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.1430
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K173238
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 | |||
|---|---|---|---|---|
| D-Piece™ | D-PIECE-3 / D-Piece™ | 05060246860238 | On the market | |
| SteriBreath™ Eco Mouthpiece | STERIBREATH-ECO / SteriBreath™ Eco Mouthpiece | 05060246860474 | On the market | |
| ToxCO | TOXCO-USA / ToxCO | 05060246860030 | On the market |
Similar devices
Other devices filed under FDA product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase).
- Minico by Catalyst Research Corp.
- Cosense Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase by Capnia, Inc.
- MICROCO by Micro Direct, Inc.
- Ecolyzer #200/COHB Analyzer Sys by Bd Becton Dickinson Vacutainer Systems Preanalytic
- Carbon Monoxide Breath Sensor System (COBSS) by Carrot Sense, Inc.
- VITALOGRAPH-BREATHCO MONITOR by Vitalograph, Ltd.
- CO TEST by Erich Jaeger GmbH
- Pivot Breath Sensor by Carrot, Inc.
- ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT by Sherwood Medical Co.
- CD-102 CARBON DIOXIDE ANALYZER/RECOR by Instrumentarium Corp.