FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
reSET-O
K Number: K173681
·
Decision Dec 10, 2018
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
3
Review Days
374
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Basic Information
- Device Name
- reSET-O
- K Number
- K173681
- 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
- December 1, 2017
- Decision Date
- December 10, 2018
- Product Code
- PWE
- 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 |
|---|---|---|---|
| PWE | Computerized Behavioral Therapy Device For Substance Use Disorders | FDA class 2 | Neurology |
Similar 510(k) Clearances
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