K191716 is an FDA 510(k) clearance for the Somryst. This device is classified as a Computerized Behavioral Therapy Device For Insomnia (Class II - Special Controls, product code QVO).
Submitted by Pear Therapeutics, Inc. (San Francisco, US). The FDA issued a Cleared decision on March 23, 2020, 271 days after receiving the submission on June 26, 2019.
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 | K191716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2019 |
| Decision Date | March 23, 2020 |
| Days to Decision | 271 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. |