FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOCUS VNG/ENG TYPE 1068
K Number: K061791
·
Decision Jul 11, 2006
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
58
Applicant Total
6
Review Days
15
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FOCUS VNG/ENG TYPE 1068
- K Number
- K061791
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1460
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gn Otometrics A/S
- Date Received
- June 26, 2006
- Decision Date
- July 11, 2006
- Product Code
- GWN
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWN | Nystagmograph | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWN), ordered by most recent decision date.
NeuroEars-Anna
FDA 510(k)
FDA Class 2
·Neurology
ICS Dizcovery (1091)
FDA 510(k)
FDA Class 2
·Neurology
Synapsys VHIT
FDA 510(k)
FDA Class 2
·Neurology
NeuroSwift Pro
FDA 510(k)
FDA Class 2
·Neurology
Insight Infrared Video Goggles
FDA 510(k)
FDA Class 2
·Neurology
VisualEyes
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Gn Otometrics A/S
| K Number | Device Name | ||
|---|---|---|---|
| K143670 | ICS CHARTR EP 200 WITH VEMP | Oct 23, 2015 | Substantially Equivalent |
| K110286 | GN OTOMETRICS TYPE 1053 FREEFIT | Apr 28, 2011 | Substantially Equivalent |
| K083399 | ICS CHARTR EP 200 | Feb 20, 2009 | Substantially Equivalent |
| K061104 | SPEECHLINK 100 TYPE 1053 | May 3, 2006 | Substantially Equivalent |
| K033645 | OTOFLEX 100 TYE 1012 | Mar 31, 2004 | Substantially Equivalent |