Screen, Tangent, Ac-powered (campimeter)

Device Code: 4257

Product Code(s): HOM

Device Classification Information

Device Type ID4257
Device NameScreen, Tangent, Ac-powered (campimeter)
Regulation DescriptionTangent Screen (campimeter).
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 Number886.1810 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHOM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4257
DeviceScreen, Tangent, Ac-powered (campimeter)
Product CodeHOM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTangent Screen (campimeter).
CFR Regulation Number886.1810 [🔎]
TPLC Last Update: 2019-04-02 20:45:38

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