K201206 is an FDA 510(k) clearance for the Pivot Breath Sensor. This device is classified as a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II - Special Controls, product code CCJ).
Submitted by Carrot, Inc. (Redwood City, US). The FDA issued a Cleared decision on June 30, 2021, 422 days after receiving the submission on May 4, 2020.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 868.1430.
| 510(k) Number | K201206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2020 |
| Decision Date | June 30, 2021 |
| Days to Decision | 422 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | CCJ - Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1430 |