FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
K Number: K983046
·
Decision Nov 17, 1998
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
69
Applicant Total
20
Review Days
77
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Basic Information
- Device Name
- AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
- K Number
- K983046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1090
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Electromedics Corp.
- Date Received
- September 1, 1998
- Decision Date
- November 17, 1998
- Product Code
- ETY
- 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 |
|---|---|---|---|
| ETY | Tester, Auditory Impedance | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by American Electromedics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K983051 | AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | Nov 18, 1998 | Substantially Equivalent |
| K983049 | AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER | Nov 18, 1998 | Substantially Equivalent |
| K983048 | AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | Nov 17, 1998 | Substantially Equivalent |
| K972221 | K 15 AUDIOMETER | Sep 8, 1997 | Substantially Equivalent |
| K970279 | RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) | Mar 18, 1997 | Substantially Equivalent |
| K955289 | RACE CAR TYMPANOMETER | Dec 8, 1995 | Substantially Equivalent |
| K951527 | THE PILOT AUDIOMETER | May 3, 1995 | Substantially Equivalent |
| K930164 | THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S | Apr 23, 1993 | Substantially Equivalent |
| K924933 | AE-206 TYMPNOMWRWE(R) AUDIOMETER | Jan 21, 1993 | Substantially Equivalent |
| K924934 | AUTOMATIC IMPEDANCE METER AE-205 | Jan 21, 1993 | Substantially Equivalent |