Maxxi Position Sensor
FDA 510(k) clearance K191492 · decided 2020-04-24
Clearance details
- K-number
- K191492
- Device name
- Maxxi Position Sensor
- Applicant
- Neurovirtual USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-06-05
- Decision date
- 2020-04-24
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- GWQ
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fort Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.