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ClarifEye R1.0, ClarifEye Needle

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201743
510(k) Type
Abbreviated
Applicant
Philips Medical Systems Nederlands B.V.
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
2/23/2021
Days to Decision
243 days
Submission Type
Summary

ClarifEye R1.0, ClarifEye Needle

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201743
510(k) Type
Abbreviated
Applicant
Philips Medical Systems Nederlands B.V.
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
2/23/2021
Days to Decision
243 days
Submission Type
Summary