Sleepio®— 510(k) K233577
Substantially EquivalentBig Health, Inc.
FDA 510(k) clearance K233577 for Sleepio®, Substantially Equivalent on 2024-08-05. Applicant: Big Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Big Health, Inc.
- Product code
- Code QVO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5801
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Recent devices under product code QVO
view allMore clearances from Big Health, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.