Last synced on 2 December 2022 at 11:04 pm

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191457
510(k) Type
Traditional
Applicant
MED-EL Elektromedizinische Geraete GmbH
Country
Austria
FDA Decision
Substantially Equivalent
Decision Date
9/18/2019
Days to Decision
110 days
Submission Type
Statement

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191457
510(k) Type
Traditional
Applicant
MED-EL Elektromedizinische Geraete GmbH
Country
Austria
FDA Decision
Substantially Equivalent
Decision Date
9/18/2019
Days to Decision
110 days
Submission Type
Statement