K132775 is an FDA 510(k) clearance for the PONTO PLUS AND PONTO PLUS POWER. 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 December 9, 2013, 95 days after receiving the submission on September 5, 2013.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K132775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2013 |
| Decision Date | December 09, 2013 |
| Days to Decision | 95 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 |