FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ICS IMPULSE
K Number: K122550
·
Decision Feb 1, 2013
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
58
Applicant Total
8
Review Days
164
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
- ICS IMPULSE
- K Number
- K122550
- 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
- Date Received
- August 21, 2012
- Decision Date
- February 1, 2013
- Product Code
- GWN
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
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
| K Number | Device Name | ||
|---|---|---|---|
| K161707 | Madsen Zodiac | Sep 1, 2016 | Substantially Equivalent |
| K151504 | ICS Impulse | Nov 16, 2015 | Substantially Equivalent |
| K132957 | MADSEN ACCUSCREEN TYPE 1077 | Feb 27, 2014 | Substantially Equivalent |
| K122028 | AURICAL HIT | Oct 23, 2012 | Substantially Equivalent |
| K122067 | TYPE 1077 ACCUSCREEN | Sep 27, 2012 | Substantially Equivalent |
| K092373 | ICS CHARTR EP 200 | Sep 3, 2009 | Substantially Equivalent |
| K081234 | GN OTOMETRICS INSERT EARPHONES | Jul 14, 2008 | Substantially Equivalent |