Medical Computers And Software For Ophthalmic Use

Device Code: 4433

Product Code(s): LQB

Device Classification Information

Device Type ID4433
Device NameMedical Computers And Software For Ophthalmic Use
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 TypeContact ODE
FDA Device ClassificationClass 3 Medical Device
Product CodeLQB
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4433
DeviceMedical Computers And Software For Ophthalmic Use
Product CodeLQB
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:49:02

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