The following data is part of a premarket notification filed by Nuheara Limited with the FDA for Nuheara Iqbuds 2 Pro Hearing Aid.
| Device ID | K221064 |
| 510k Number | K221064 |
| Device Name: | Nuheara IQbuds 2 PRO Hearing Aid |
| Classification | Self-fitting Air-conduction Hearing Aid, Over The Counter |
| Applicant | Nuheara Limited 13555 S.E. 36th St., Suite 100 Bellevue, WA 98006 |
| Contact | John Luna |
| Correspondent | Deborah Arthur DArthurConsulting 4830 Randolph Rd., Unit 3302 Charlotte, NC 28211 |
| Product Code | QUH |
| CFR Regulation Number | 874.3325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-11 |
| Decision Date | 2022-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850000562004 | K221064 | 000 |