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AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231709
510(k) Type
Traditional
Applicant
Radmedix LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/12/2023
Days to Decision
30 days
Submission Type
Summary

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231709
510(k) Type
Traditional
Applicant
Radmedix LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/12/2023
Days to Decision
30 days
Submission Type
Summary