The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cochlear Osia Osi200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia Smartapp, Cochlear Osia Surgical Instruments.
| Device ID | K191921 |
| 510k Number | K191921 |
| Device Name: | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments |
| Classification | Active Implantable Bone Conduction Hearing System |
| Applicant | Cochlear Americas 13059 E Peakview Avenue Centennial, CO 80111 |
| Contact | Chinda Hemmavanh |
| Correspondent | Chinda Hemmavanh 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 | 2019-07-18 |
| Decision Date | 2019-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502046626 | K191921 | 000 |
| 09321502044899 | K191921 | 000 |
| 09321502044905 | K191921 | 000 |
| 09321502046138 | K191921 | 000 |
| 09321502046145 | K191921 | 000 |
| 09321502046503 | K191921 | 000 |
| 09321502045063 | K191921 | 000 |
| 09321502046527 | K191921 | 000 |
| 09321502046534 | K191921 | 000 |
| 09321502044967 | K191921 | 000 |
| 09321502045124 | K191921 | 000 |
| 09321502045131 | K191921 | 000 |
| 09321502045148 | K191921 | 000 |
| 09321502046589 | K191921 | 000 |
| 09321502046596 | K191921 | 000 |
| 09321502046602 | K191921 | 000 |
| 09321502046619 | K191921 | 000 |
| 09321502074131 | K191921 | 000 |