510(k) K221064
- Device
- Nuheara IQbuds 2 PRO Hearing Aid
- Applicant
- Nuheara Limited
- 510(k) number
- K221064
- Product code
- QUH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-30
- Date received
- 2022-04-11
- 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
- John Luna
- Address
- 13555 SE 36th St., Suite 100 Bellevue WA US 98006 98006
FDA Registration Numbers#
- 3018940143
- 3023339161
- 3010841212
- 3003426343
- 3039409159
- 2182204
- 3008941158
- 3030627827
- 3013294311
- 3015651976
- 3003303986
- 3011586575
- 3026048380
- 3040068315
- 3041658266
- 3002808415
- 3015246392
- 3007344957
- 3005650109
- 3006011998
- 3005085999
- 3006312495
- 3011927597
- 3024991168
- 3005019184
- 3008848788
- 3027202846
- 3015527983
- 3014337591
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 |
| K223848 | Intrisound™ Tuned Lumen® 155 Hearing Aids | Tuned , Ltd. | 2023-09-08 |
| 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 |
Legacy Summary#
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FDA Review#
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