Last synced on 17 May 2024 at 11:06 pm

Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231204
510(k) Type
Traditional
Applicant
Cochlear
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/18/2023
Days to Decision
113 days
Submission Type
Summary

Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231204
510(k) Type
Traditional
Applicant
Cochlear
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/18/2023
Days to Decision
113 days
Submission Type
Summary