Drum, Opticokinetic

Device Code: 4265

Product Code(s): HOW

Device Classification Information

Device Type ID4265
Device NameDrum, Opticokinetic
Regulation DescriptionOptokinetic Drum.
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 Number886.1200 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHOW
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4265
DeviceDrum, Opticokinetic
Product CodeHOW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOptokinetic Drum.
CFR Regulation Number886.1200 [🔎]
TPLC Last Update: 2019-04-02 20:45:46

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.