Maico MA52
FDA 510(k) K971080 · Bernafon-Maico, Inc.
510(k) numberK971080
Submission
- Device name
- Maico MA52
- Applicant
- Bernafon-Maico, Inc.
Eden Prairie, MN, US - Received
- March 25, 1997
- Decision date
- June 6, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EWO – Audiometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1050
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EWO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234095 | OtoNova/OtoNova ProEWO · Traditional | Otodynamics | 06/21/2024SE |
| K240430 | Otoport ProEWO · Special | Otodynamics, Ltd. | 03/15/2024SE |
| K231545 | hearOAEEWO · Traditional | Hearx SA (Pty) , Ltd. | 10/27/2023SE |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEEWO · Traditional | Path Medical GmbH | 06/22/2022SE |
| K191372 | LyraEWO · Traditional | Interacoustics A/S | 07/15/2019SE |
| 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 |
|---|---|---|
| K982723 | Maico MA42EWO · Traditional | 10/28/1998SE |
| K981142 | Maico MA53EWO · Traditional | 04/22/1998SE |
| K974211 | Opus 2 - Full Concha Series - IteESD · Traditional | 12/15/1997SE |
| K974152 | Opus 2 - Completely-In-Canal Series (Cic)ESD · Traditional | 12/15/1997SE |
| K974069 | Opus 2 - Canal Series (Itc)ESD · Traditional | 12/15/1997SE |
| K973948 | Dualine 100 BteESD · Traditional | 10/28/1997SE |
| K971158 | Dualine 400 CicESD · Traditional | 06/13/1997SE |
| K962275 | Maico MA25 Series II with SpeechEWO · Traditional | 09/05/1996SE |
Questions and answers
When was Maico MA52 cleared by the FDA?
Maico MA52 (K971080) received a 510(k) decision of Substantially Equivalent on June 6, 1997, 73 days after the submission was received.
What is the product code of K971080?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.