K090996 is an FDA 510(k) clearance for the PONTO PRO. This device is classified as a Hearing Aid, Bone Conduction (Class II - Special Controls, product code LXB).
Submitted by Oticon Medical AB (Gothenburg, Askim, SE). The FDA issued a Cleared decision on July 29, 2009, 112 days after receiving the submission on April 8, 2009.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K090996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2009 |
| Decision Date | July 29, 2009 |
| Days to Decision | 112 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 |