PONTO PRO
Hearing Aid, Bone Conduction
OTICON MEDICAL AB
The following data is part of a premarket notification filed by Oticon Medical Ab with the FDA for Ponto Pro.
Pre-market Notification Details
| Device ID | K090996 |
| 510k Number | K090996 |
| Device Name: | PONTO PRO |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | OTICON MEDICAL AB EKONOMIV 2 Gothenburg, Askim, SE Se-436 33 |
| Contact | Karolin Isberg |
| Correspondent | Karolin Isberg OTICON MEDICAL AB EKONOMIV 2 Gothenburg, Askim, SE Se-436 33 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-08 |
| Decision Date | 2009-07-29 |
| Summary: | summary |
Trademark Results [PONTO PRO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PONTO PRO 77914851 3896329 Dead/Cancelled |
Oticon Medical A/S 2010-01-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.