K161671 is an FDA 510(k) clearance for the Ponto 3, Ponto 3 Power and Ponto 3 SuperPower. 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 September 29, 2016, 105 days after receiving the submission on June 16, 2016.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K161671 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2016 |
| Decision Date | September 29, 2016 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| 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 |