Last synced on 2 June 2023 at 11:04 pm

Ponto 3, Ponto 3 Power and Ponto 3 SuperPower

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161671
510(k) Type
Traditional
Applicant
OTICON MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
9/29/2016
Days to Decision
105 days
Submission Type
Summary

Ponto 3, Ponto 3 Power and Ponto 3 SuperPower

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161671
510(k) Type
Traditional
Applicant
OTICON MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
9/29/2016
Days to Decision
105 days
Submission Type
Summary