Interacoustics Model AD226 Diagnostic Audiometer
FDA 510(k) K981327 · Idem (Int'L Dist. of Electronics For Medicine)
510(k) numberK981327
Submission
- Device name
- Interacoustics Model AD226 Diagnostic Audiometer
- Applicant
- Idem (Int'L Dist. of Electronics For Medicine)
Benicia, CA, US - Received
- April 13, 1998
- Decision date
- May 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EWO – Audiometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1050
- Specialty
- Ear, Nose, Throat
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| K180287 | GSI CortiEWO · Traditional | Grason-Stadler, Inc. | 05/11/2018SE |
| K173567 | SeraEWO · Traditional | Interacoustics A/S | 02/14/2018SE |
| K172403 | GSI NovusEWO · Traditional | Grason-Stadler, Inc. | 10/20/2017SE |
| K171506 | EasyscreenEWO · Traditional | Maico Diagnostics GmbH | 08/29/2017SE |
| K151025 | iHearTestEWO · Traditional | Ihear Medical, Inc. | 12/29/2015SE |
More from Ihear Medical, Inc.
| 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 |
| K990585 | Interacoustics AT22T Automatic 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 |
Questions and answers
When was Interacoustics Model AD226 Diagnostic Audiometer cleared by the FDA?
Interacoustics Model AD226 Diagnostic Audiometer (K981327) received a 510(k) decision of Substantially Equivalent on May 11, 1998, 28 days after the submission was received.
What is the product code of K981327?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.