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NFC-600 Automated Portable Retinal Camera

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210197
510(k) Type
Special
Applicant
Crystalvue Medical Corporation
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
4/13/2021
Days to Decision
78 days
Submission Type
Summary

NFC-600 Automated Portable Retinal Camera

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210197
510(k) Type
Special
Applicant
Crystalvue Medical Corporation
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
4/13/2021
Days to Decision
78 days
Submission Type
Summary