Automatic Impedance Meter AE-205
FDA 510(k) K924934 · American Electromedics Corp.
510(k) numberK924934
Submission
- Device name
- Automatic Impedance Meter AE-205
- Applicant
- American Electromedics Corp.
Amherst, NH, US - Received
- September 30, 1992
- Decision date
- January 21, 1993
- 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
Other 510(k)s with product code ETY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183201 | Hearing Healthcare ProETY · Traditional | Db Diagnostic Systems, Inc. | 03/06/2019SE |
| K171038 | Hearing Healthcare ProETY · Traditional | Db Diagnostic Systems, Inc. | 08/02/2017SE |
| K162210 | touchTympETY · Special | Maico Diagnostics GmbH | 11/16/2016SE |
| K161707 | Madsen ZodiacETY · Special | Gn Otometrics | 09/01/2016SE |
| K151616 | AT235ETY · Special | Interacoustics A/S | 07/15/2015SE |
| K151509 | GSI TympStar Pro Middle Ear AnalyzerETY · Traditional | Diagnostic Group, Dba Grason-Stadler | 06/25/2015SE |
| K133013 | Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus…ETY · Traditional | Inventis S.R.L. | 01/24/2014SE |
| K121847 | TitanETY · Traditional | Interacoustics A/S | 11/29/2012SE |
| K083861 | Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module…ETY · Traditional | Interacoustics AS | 04/09/2009SE |
| K081841 | Amplivox Otowave 102 Hand Held Portable TympanometerETY · Traditional | Amplivox, Ltd. | 07/16/2008SE |
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 |
| K955289 | Race Car TympanometerETY · Traditional | 12/08/1995SE |
| K951527 | The Pilot AudiometerEWO · Traditional | 05/03/1995SE |
| K930164 | The Automatic Impedance Meter,Model AE-208D/SETY · Traditional | 04/23/1993SE |
| K924933 | AE-206 Tympnomwrwe(R) AudiometerETY · Traditional | 01/21/1993SE |
Questions and answers
When was Automatic Impedance Meter AE-205 cleared by the FDA?
Automatic Impedance Meter AE-205 (K924934) received a 510(k) decision of Substantially Equivalent on January 21, 1993, 113 days after the submission was received.
What is the product code of K924934?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.