I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
FDA 510(k) clearance K192186 · decided 2019-11-29
Clearance details
- K-number
- K192186
- Device name
- I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
- Applicant
- Neurolign USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-08-12
- Decision date
- 2019-11-29
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- GWN
- Device class
- 2
- Regulation number
- 882.1460
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.