K211640 is an FDA 510(k) clearance for the Ponto 5 Mini. This device is classified as a Hearing Aid, Bone Conduction (Class II - Special Controls, product code LXB).
Submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on August 10, 2021, 75 days after receiving the submission on May 27, 2021.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K211640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2021 |
| Decision Date | August 10, 2021 |
| Days to Decision | 75 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LXB - Hearing Aid, Bone Conduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3302 |