COCHLEAR BAHA IMPLANT SYSTEM— 510(k) K121317
Substantially EquivalentCochlear Americas
FDA 510(k) clearance K121317 for COCHLEAR BAHA IMPLANT SYSTEM, Substantially Equivalent on 2012-10-12. Applicant: Cochlear Americas. Device class: 2.
Clearance details
- Applicant
- Cochlear Americas
- Product code
- Code MAH
- Device class
- Class 2
- Regulation
- 21 CFR 874.3302
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Centennial, CO, US
Recent devices under product code MAH
view allMore clearances from Cochlear Americas
view all- K260902 — Cochlear Osia® 3(I) Sound Processor +6 more
- K240155 — Cochlear Osia System
- K231604 — Instrument Case
- K220922 — Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
- K212136 — Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
Adverse events under product code MAH
product code MAH- Injury
- 4,155
- Total
- 4,155
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.