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Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180378
510(k) Type
Traditional
Applicant
Optomed Oy
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
4/5/2018
Days to Decision
52 days
Submission Type
Summary

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180378
510(k) Type
Traditional
Applicant
Optomed Oy
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
4/5/2018
Days to Decision
52 days
Submission Type
Summary