Race Car Tympanometer
FDA 510(k) K955289 · American Electromedics Corp.
510(k) numberK955289
Submission
- Device name
- Race Car Tympanometer
- Applicant
- American Electromedics Corp.
Amherst, NH, US - Received
- November 16, 1995
- Decision date
- December 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ETY – Tester, Auditory Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1090
- Specialty
- Ear, Nose, Throat
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More from Amplivox, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K983051 | American Electromedics Race Ca Tympanometer/Audiometer with Integral PrinterETY · Traditional | 11/18/1998SE |
| K983049 | American Electromedics Quik Tymp 1 (QT1) Tympanometer with Intergral PrinterETY · Traditional | 11/18/1998SE |
| K983048 | American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer with Integral PrinterEWO · Traditional | 11/17/1998SE |
| K983046 | American Electromedics Race Car Tympanometer W/Integral PrinterETY · Traditional | 11/17/1998SE |
| K972221 | K 15 AudiometerEWO · Traditional | 09/08/1997SE |
| K970279 | Race Car Tympanometer with Audiometer(Ae-Rcaud I/Quik Tymp 1(AE-QUIK 1)/QUICK Tymp…EWO · Traditional | 03/18/1997SE |
| K951527 | The Pilot AudiometerEWO · Traditional | 05/03/1995SE |
| K930164 | The Automatic Impedance Meter,Model AE-208D/SETY · Traditional | 04/23/1993SE |
| K924934 | Automatic Impedance Meter AE-205ETY · Traditional | 01/21/1993SE |
| K924933 | AE-206 Tympnomwrwe(R) AudiometerETY · Traditional | 01/21/1993SE |
Questions and answers
When was Race Car Tympanometer cleared by the FDA?
Race Car Tympanometer (K955289) received a 510(k) decision of Substantially Equivalent on December 8, 1995, 22 days after the submission was received.
What is the product code of K955289?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.