510(k) K130201
K130201 is an FDA 510(k) premarket notification submitted by Ototronix, LLC for the device "NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 26, 2013. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Ototronix, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2013
- Date Received
- January 28, 2013
- 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