FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
ICS CHARTR EP 200 WITH VEMP
K Number: K143670
·
Decision Oct 23, 2015
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
6
Review Days
303
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 CHARTR EP 200 WITH VEMP
- K Number
- K143670
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gn Otometrics A/S
- Date Received
- December 24, 2014
- Decision Date
- October 23, 2015
- Product Code
- GWJ
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWJ), ordered by most recent decision date.
Integrity V500 (Integrity, Integrity with VEMP)
FDA 510(k)
FDA Class 2
·Neurology
ALGO Pro Newborn Hearing Screener (ALGO Pro)
FDA 510(k)
FDA Class 2
·Neurology
QScreen
FDA 510(k)
FDA Class 2
·Neurology
ALGO 7i
FDA 510(k)
FDA Class 2
·Neurology
GSI Audera Pro
FDA 510(k)
FDA Class 2
·Neurology
SmartEP
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Gn Otometrics A/S
| K Number | Device Name | ||
|---|---|---|---|
| K110286 | GN OTOMETRICS TYPE 1053 FREEFIT | Apr 28, 2011 | Substantially Equivalent |
| K083399 | ICS CHARTR EP 200 | Feb 20, 2009 | Substantially Equivalent |
| K061791 | FOCUS VNG/ENG TYPE 1068 | Jul 11, 2006 | Substantially Equivalent |
| K061104 | SPEECHLINK 100 TYPE 1053 | May 3, 2006 | Substantially Equivalent |
| K033645 | OTOFLEX 100 TYE 1012 | Mar 31, 2004 | Substantially Equivalent |