Last synced on 2 December 2022 at 11:04 pm

Ponto Bone Anchored Hearing System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152820
510(k) Type
Traditional
Applicant
OTICON MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
1/22/2016
Days to Decision
116 days
Submission Type
Summary

Ponto Bone Anchored Hearing System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152820
510(k) Type
Traditional
Applicant
OTICON MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
1/22/2016
Days to Decision
116 days
Submission Type
Summary