Device Classification Name |
active implantable bone conduction hearing system
|
510(k) Number |
K190589 |
Device Name |
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments |
Applicant |
Cochlear Americas |
13059 E. Peakview Avenue |
Centennial,
CO
80111
|
|
Applicant Contact |
Laura Blair |
Correspondent |
Cochlear Americas |
13059 E. Peakview Avenue |
Centennial,
CO
80111
|
|
Correspondent Contact |
Laura Blair |
Regulation Number | 874.3340
|
Classification Product Code |
|
Date Received | 03/07/2019 |
Decision Date | 07/03/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT03086135 NCT03509974
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|