MindsEye Expandable Port
FDA 510(k) clearance K202072 · decided 2020-08-26
Clearance details
- K-number
- K202072
- Device name
- MindsEye Expandable Port
- Applicant
- Minnetronix Neuro, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-27
- Decision date
- 2020-08-26
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- GZT
- Device class
- 2
- Regulation number
- 882.4800
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- St Paul, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.