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Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190589
510(k) Type
Traditional
Applicant
Cochlear Americas
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/3/2019
Days to Decision
118 days
Submission Type
Summary

Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190589
510(k) Type
Traditional
Applicant
Cochlear Americas
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/3/2019
Days to Decision
118 days
Submission Type
Summary