510(k) K223848
- Device
- Intrisound? Tuned Lumen® 155 Hearing Aids
- Applicant
- Tuned , Ltd.
- 510(k) number
- K223848
- Product code
- QUH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-08
- Date received
- 2022-12-22
- Regulation
- 874.3325
- Classification name
- Self-Fitting Air-Conduction Hearing Aid, Over The Counter
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Orit lanco
- Address
- 18 Harimon St. Gan Yoshiya IL 3885000 3885000
FDA Registration Numbers#
- 3011586575
- 3039409159
- 3018940143
- 3005019184
- 3027202846
- 2182204
- 3005650109
- 3026048380
- 3005085999
- 3010841212
- 3041658266
- 3015527983
- 3014337591
- 3008941158
- 3015651976
- 3011927597
- 3003303986
- 3006312495
- 3030627827
- 3007344957
- 3006011998
- 3008848788
- 3002808415
- 3015246392
- 3003426343
- 3013294311
- 3040068315
- 3023339161
- 3024991168
Source Documents#
Other 510(k) Records For Product Code QUH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233747 | Concha Sol Hearing Aids (CL-1001) | Concha Labs | 2024-03-15 |
| K233464 | WSA Self-Fitting Hearing Aid Gen 2 | Wsaud A/S | 2024-02-09 |
| K231550 | Sontro® OTC Hearing Aids (AI) | Soundwave Hearing, LLC | 2023-10-26 |
| K221052 | Self-Fitting hearing aids | Huizhou Jinghao Medical Technology Co., Ltd. | 2023-09-25 |
| K230538 | All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid | Sonova AG | 2023-06-16 |
| K223137 | Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application | Hearx SA (Pty) , Ltd. | 2023-03-14 |
| K221698 | Eargo 5 , Eargo 6 | Eargo, Inc. | 2022-12-21 |
| K221064 | Nuheara IQbuds 2 PRO Hearing Aid | Nuheara Limited | 2022-10-30 |