Chart, Visual Acuity

Device Code: 4266

Product Code(s): HOX

Device Classification Information

Device Type ID4266
Device NameChart, Visual Acuity
Regulation DescriptionVisual Acuity Chart.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission Type510(K) Exempt
CFR Regulation Number886.1150 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHOX
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4266
DeviceChart, Visual Acuity
Product CodeHOX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionVisual Acuity Chart.
CFR Regulation Number886.1150 [🔎]
TPLC Last Update: 2019-04-02 20:45:47

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