The following data is part of a premarket notification filed by Gn Hearing A/s with the FDA for Jabra Enhance Plus.
| Device ID | K213424 |
| 510k Number | K213424 |
| Device Name: | Jabra Enhance Plus |
| Classification | Self-fitting Air-conduction Hearing Aid |
| Applicant | GN Hearing A/S Lautrupbjerg 7 Ballerup, DK Dk-2750 |
| Contact | Lars Hagander |
| Correspondent | Lars Hagander GN Hearing A/S Lautrupbjerg 7 Ballerup, DK Dk-2750 |
| Product Code | QDD |
| CFR Regulation Number | 874.3325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-21 |
| Decision Date | 2022-01-19 |