510(k) K013060
K013060 is an FDA 510(k) premarket notification submitted by Ics Medical for the device "ICS MEDICAL MODEL VG-30 VIDEO GOGGLES". The FDA issued a decision of Substantially Equivalent on December 10, 2001. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Ics Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2001
- Date Received
- September 11, 2001
- 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