FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
K Number: K002985
·
Decision Dec 13, 2000
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
10
Review Days
79
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 MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
- K Number
- K002985
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ics Medical Corp.
- Date Received
- September 25, 2000
- Decision Date
- December 13, 2000
- 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 Ics Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K011181 | ICS MEDICAL CHARTR OAE WITH TYMP | Jun 25, 2001 | Substantially Equivalent |
| K991497 | ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM | Jul 28, 1999 | Substantially Equivalent |
| K972631 | ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER | Sep 22, 1997 | Substantially Equivalent |
| K960097 | CHARTR EP | Feb 21, 1997 | Substantially Equivalent |
| K931609 | CHARTR ENG SYSTEM | Sep 26, 1995 | Substantially Equivalent |
| K931608 | NCA-200 | Jun 22, 1993 | Substantially Equivalent |
| K925237 | AUTOMATIC CALORIC IRRIGATION SYSTEM | May 5, 1993 | Substantially Equivalent |
| K881630 | AUTOMATIC CALORIC IRRIGATION SYSTEM | Jun 21, 1988 | Substantially Equivalent |
| K872093 | RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING | Sep 16, 1987 | Substantially Equivalent |