FDA Product Code
FDA Product Code QVO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5801
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233577 | Sleepio® | Big Health, Inc. | 2024-08-05 | Traditional | PDF ↗ |
| K191716 | Somryst | Pear Therapeutics, Inc. | 2020-03-23 | Traditional | PDF ↗ |
Product code QVO · Class II · Neurology. Data: openFDA.