The following data is part of a premarket notification filed by Oticon Medical Ab with the FDA for Ponto Pro.
| 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 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  PONTO PRO  77914851  3896329 Dead/Cancelled | Oticon Medical A/S 2010-01-19 |