Sleepio®— 510(k) K233577

Substantially Equivalent

Big Health, Inc.

FDA 510(k) clearance K233577 for Sleepio®, Substantially Equivalent on 2024-08-05. Applicant: Big Health, Inc..

Clearance details

Applicant
Big Health, Inc.
Product code
Code QVO
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Francisco, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.