Tester, Color Vision

Device Code: 4137

Product Code(s): HIT

Device Classification Information

Device Type ID4137
Device NameTester, Color Vision
Regulation DescriptionColor Vision Tester.
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 Number886.1170 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHIT
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4137
DeviceTester, Color Vision
Product CodeHIT
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionColor Vision Tester.
CFR Regulation Number886.1170 [🔎]
TPLC Last Update: 2019-04-02 20:43:38

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