The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cochlear Osia Osi100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments.
| Device ID | K190589 |
| 510k Number | K190589 |
| Device Name: | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments |
| Classification | Active Implantable Bone Conduction Hearing System |
| Applicant | Cochlear Americas 13059 E. Peakview Avenue Centennial, CO 80111 |
| Contact | Laura Blair |
| Correspondent | Laura Blair Cochlear Americas 13059 E. Peakview Avenue Centennial, CO 80111 |
| Product Code | PFO |
| CFR Regulation Number | 874.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-07 |
| Decision Date | 2019-07-03 |