K233577
- 510(k) number
- K233577
- Device name
- Sleepio®
- Applicant
- Big Health, Inc. CA · US
- Product code
- QVO — Computerized Behavioral Therapy Device For Insomnia
- Decision date
- 2024-08-05
- Date received
- 2023-11-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K233577.pdf
Official FDA record: K233577
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.