510(k) K163558
K163558 is an FDA 510(k) premarket notification submitted by Synapsys SA for the device "Synapsys Ulmer Video Nystagmograph". The FDA issued a decision of Substantially Equivalent on March 23, 2017. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Synapsys SA has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2017
- Date Received
- December 19, 2016
- Clearance Type
- Special
- 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