FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
reSet
K Number: DEN160018
·
Decision Sep 14, 2017
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
3
Review Days
486
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Basic Information
- Device Name
- reSet
- K Number
- DEN160018
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.5801
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Pear Therapeutics, Inc.
- Date Received
- May 16, 2016
- Decision Date
- September 14, 2017
- 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 |
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