FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE PILOT AUDIOMETER
K Number: K951527
·
Decision May 3, 1995
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
20
Review Days
30
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Basic Information
- Device Name
- THE PILOT AUDIOMETER
- K Number
- K951527
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Electromedics Corp.
- Date Received
- April 3, 1995
- Decision Date
- May 3, 1995
- 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 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 |
| K983046 | AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER | Nov 17, 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 |
| 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 |