Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments— 510(k) K191921
Substantially EquivalentCochlear Americas
FDA 510(k) clearance K191921 for Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments, Substantially Equivalent on 2019-11-15. Applicant: Cochlear Americas.
Clearance details
- Applicant
- Cochlear Americas
- Product code
- Code PFO
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Centennial, CO, US
Adverse events under product code PFO
product code PFO- Injury
- 2,752
- Total
- 2,752
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.