Interacoustics Automatic Impedance Audiometer
FDA 510(k) K942008 · Precision Acoustics Ind., Inc.
510(k) numberK942008
Submission
- Device name
- Interacoustics Automatic Impedance Audiometer
- Applicant
- Precision Acoustics Ind., Inc.
New York, NY, US - Received
- April 25, 1994
- Decision date
- August 24, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K943607 | Interacoustics Hearing Aid Analyzer MS 40ETW · Traditional | 09/23/1994SE |
| K941920 | Interacoustics Clinical AudiometerEWO · Traditional | 09/16/1994SE |
| K943066 | Interacoustics Computer Audiometer Ba 20EWO · Traditional | 08/24/1994SE |
| K942007 | Interacoustics Clinical Impedance Audiometer AZ26ETY · Traditional | 08/24/1994SE |
| K943065 | Interacoustics Clinical AudiometerEWO · Traditional | 08/17/1994SE |
| K942006 | Interacoustics Diagnostic AudiometerEWO · Traditional | 06/20/1994SE |
| K941848 | Interacoustics. Hearing Aid AnalyzerETW · Traditional | 05/23/1994SE |
| K930260 | Acoustic Analyzer AA30EWO · Traditional | 07/13/1993SE |
Questions and answers
When was Interacoustics Automatic Impedance Audiometer cleared by the FDA?
Interacoustics Automatic Impedance Audiometer (K942008) received a 510(k) decision of Substantially Equivalent on August 24, 1994, 121 days after the submission was received.
What is the product code of K942008?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.