FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Somryst
K Number: K191716
·
Decision Mar 23, 2020
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
3
Review Days
271
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Basic Information
- Device Name
- Somryst
- K Number
- K191716
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5801
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pear Therapeutics, Inc.
- Date Received
- June 26, 2019
- Decision Date
- March 23, 2020
- Product Code
- QVO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QVO | Computerized Behavioral Therapy Device For Insomnia | FDA class 2 | Neurology |
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