NeuroCap
FDA 510(k) clearance K172866 · decided 2018-04-27
Clearance details
- K-number
- K172866
- Device name
- NeuroCap
- Applicant
- Memory MD, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-20
- Decision date
- 2018-04-27
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.