Interacoustics AT22T Automatic Impedance Audiometer
FDA 510(k) K990585 · Idem (Int'L Dist. of Electronics For Medicine)
510(k) numberK990585
Submission
- Device name
- Interacoustics AT22T Automatic Impedance Audiometer
- Applicant
- Idem (Int'L Dist. of Electronics For Medicine)
Benicia, CA, US - Received
- February 23, 1999
- Decision date
- May 17, 1999
- 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 |
|---|---|---|
| K991853 | Interacoustics Ep 15 Abr Stand Alone UnitGWJ · Traditional | 10/25/1999SE |
| K990652 | Interacoustics Model AZ26 Clinical Impedance AudiometerETY · Traditional | 05/17/1999SE |
| K983832 | Interacoustics Model MT 10, Handheld Impedance AudiometerETY · Traditional | 01/25/1999SE |
| K982249 | Interacoustics Model AD229 Diagnostic AudiometerEWO · Traditional | 08/07/1998SE |
| K981327 | Interacoustics Model AD226 Diagnostic AudiometerEWO · Traditional | 05/11/1998SE |
Questions and answers
When was Interacoustics AT22T Automatic Impedance Audiometer cleared by the FDA?
Interacoustics AT22T Automatic Impedance Audiometer (K990585) received a 510(k) decision of Substantially Equivalent on May 17, 1999, 83 days after the submission was received.
What is the product code of K990585?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.