510(k) K171884
K171884 is an FDA 510(k) premarket notification submitted by Neuro Kinetics, Inc. for the device "I-Portal Portable Assessment System - Nystagmograph (I-PAS)". The FDA issued a decision of Substantially Equivalent on November 22, 2017. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Neuro Kinetics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2017
- Date Received
- June 23, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nystagmograph
- Device Class
- Class II
- Regulation Number
- 882.1460
- Review Panel
- NE
- Submission Type