The following data is part of a premarket notification filed by Carrot Inc. with the FDA for Pivot Breath Sensor.
| Device ID | K201206 |
| 510k Number | K201206 |
| Device Name: | Pivot Breath Sensor |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | Carrot Inc. 1400A Seaport Blvd, Suite 501 Redwood City, CA 94063 |
| Contact | Sara Lippert |
| Correspondent | Jonathan S. Kahan Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-04 |
| Decision Date | 2021-06-30 |