Cochlear Baha SoundArc— 510(k) K171088
Substantially EquivalentCochlear Americas
FDA 510(k) clearance K171088 for Cochlear Baha SoundArc, Substantially Equivalent on 2017-06-07. Applicant: Cochlear Americas.
Clearance details
- Applicant
- Cochlear Americas
- Product code
- Code LXB
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Centennial, CO, US
Adverse events under product code LXB
product code LXB- Injury
- 2,334
- Total
- 2,334
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.