510(k) K122550
K122550 is an FDA 510(k) premarket notification submitted by Gn Otometrics for the device "ICS IMPULSE". The FDA issued a decision of Substantially Equivalent on February 1, 2013. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Gn Otometrics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2013
- Date Received
- August 21, 2012
- 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