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Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212136
510(k) Type
Traditional
Applicant
Cochlear Americas
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/29/2021
Days to Decision
83 days
Submission Type
Summary

Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212136
510(k) Type
Traditional
Applicant
Cochlear Americas
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/29/2021
Days to Decision
83 days
Submission Type
Summary