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Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220922
510(k) Type
Traditional
Applicant
Cochlear Americas
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/27/2022
Days to Decision
118 days
Submission Type
Summary

Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220922
510(k) Type
Traditional
Applicant
Cochlear Americas
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/27/2022
Days to Decision
118 days
Submission Type
Summary