Easyscreen
510(k) K171506
Easyscreen is a medical device (FDA Class II; FDA product code EWO, Audiometer) made by MAICO Diagnostics GmbH, cleared under FDA 510(k) K171506 on 29 Aug 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171506 | Date29 Aug 2017 | StatusActive |
Official records
- FDA 510(k) database K171506
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EWO
- Device class
- Class II
- Regulation
- 21 CFR Part 874.1050
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K171506
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Maico DE easyScreen | easyScreen | 04260176121169 | — | On the market |
| Maico easyScreen | easyScreen | 04262406074184 | — | On the market |
Similar devices
Other devices filed under FDA product code EWO (Audiometer).
- Odyssey Clinical Audiometer by Qualitone
- KS 5 Clinical Audiometer by Maico Hearing Instruments, Inc.
- Digital Audiometer/Hearing Aid 3100 by FRYE ELECTRONICS, INC.
- Audiometer by Grason-Stadler, Inc.
- Aria M011160 by Intelligent Hearing Systems Corp.
- AUDIOMETER, PORTABLE, AIR CONDUCTION by Maico Hearing Instruments, Inc.
- Interacoustics OtoRead by Interacoustics A/S
- Interacoustics AD528 by Interacoustics A/S
- Infant Insert Eartips 3.5mm (bag of 20) 100906-P-20 by PATH medical GmbH
- SmartOAE by Intelligent Hearing Systems Corp.