K173238 is an FDA 510(k) clearance for the ToxCO. This device is classified as a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II - Special Controls, product code CCJ).
Submitted by Bedfont Scientific, Ltd. (Maidstone, Kent, GB). The FDA issued a Cleared decision on April 4, 2019, 546 days after receiving the submission on October 5, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1430.
| 510(k) Number | K173238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2017 |
| Decision Date | April 04, 2019 |
| Days to Decision | 546 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCJ - Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1430 |