Quell-FM
FDA 510(k) clearance DEN210046 · decided 2022-05-18
Clearance details
- K-number
- DEN210046
- Device name
- Quell-FM
- Applicant
- Neurometrix, Inc.
- Decision
- Unknown
- Date received
- 2021-10-05
- Decision date
- 2022-05-18
- Days to decision
- 225 days
- Clearance type
- Direct
- Product code
- QSQ
- Device class
- 2
- Regulation number
- 882.5888
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.