HCC
- Product code
- HCC
- Device name
- Device, Biofeedback
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5050
- Medical specialty
- Neurology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 172
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K233580 | 2024-08-01 | Deepwell Dtx, Inc. | A Breathing System (ABS) summary |
Official FDA classification page: HCC
Classification and pathway per current FDA publications. Data from openFDA (CC0).