510(k) K233577
- Device
- Sleepio®
- Applicant
- Big Health, Inc.
- 510(k) number
- K233577
- Product code
- QVO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-05
- Date received
- 2023-11-07
- Regulation
- 882.5801
- Classification name
- Computerized Behavioral Therapy Device For Insomnia
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Reuben Lawson
- Address
- 461 Bush St. Suite 200 San Francisco CA US 94108 94108
FDA Registration Numbers#
- 3024442350
- 3007389703
Source Documents#
Other 510(k) Records For Product Code QVO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191716 | Somryst | Pear Therapeutics, Inc. | 2020-03-23 |