K233577 is an FDA 510(k) clearance for the Sleepio®. This device is classified as a Computerized Behavioral Therapy Device For Insomnia (Class II - Special Controls, product code QVO).
Submitted by Big Health, Inc. (San Francisco, US). The FDA issued a Cleared decision on August 5, 2024, 272 days after receiving the submission on November 7, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5801. The Device Is Intended To Provide Cognitive Behavioral Therapy To Treat Insomnia..
| 510(k) Number | K233577 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2023 |
| Decision Date | August 05, 2024 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QVO - Computerized Behavioral Therapy Device For Insomnia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5801 |
| Definition | The Device Is Intended To Provide Cognitive Behavioral Therapy To Treat Insomnia. |