K233580 is an FDA 510(k) clearance for the A Breathing System (ABS). This device is classified as a Device, Biofeedback (Class II - Special Controls, product code HCC).
Submitted by Deepwell Dtx, Inc. (Seattle, US). The FDA issued a Cleared decision on August 1, 2024, 268 days after receiving the submission on November 7, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K233580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2023 |
| Decision Date | August 01, 2024 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCC - Device, Biofeedback |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5050 |