510(k) K152112
K152112 is an FDA 510(k) premarket notification submitted by Interacoustics A/S for the device "VisualEyes". The FDA issued a decision of Substantially Equivalent on December 29, 2015. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Interacoustics A/S has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2015
- Date Received
- July 29, 2015
- 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