FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ICS MEDICAL CHARTR OAE WITH TYMP
K Number: K011181
·
Decision Jun 25, 2001
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
10
Review Days
68
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Basic Information
- Device Name
- ICS MEDICAL CHARTR OAE WITH TYMP
- K Number
- K011181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ics Medical Corp.
- Date Received
- April 18, 2001
- Decision Date
- June 25, 2001
- Product Code
- EWO
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Ics Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K002985 | ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS | Dec 13, 2000 | 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 |