QVO
- Product code
- QVO
- Device name
- Computerized Behavioral Therapy Device For Insomnia
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5801
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
FDA classification definition
The device is intended to provide cognitive behavioral therapy to treat insomnia.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233577 | 2024-08-05 | Big Health, Inc. | Sleepio® | FDA |
Official FDA classification page: QVO
Classification and pathway per current FDA publications. Data from openFDA (CC0).