Perimeter, Ac-powered

Device Code: 4259

Product Code(s): HOO

Device Classification Information

Device Type ID4259
Device NamePerimeter, Ac-powered
Regulation DescriptionPerimeter.
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 Number886.1605 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHOO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4259
DevicePerimeter, Ac-powered
Product CodeHOO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPerimeter.
CFR Regulation Number886.1605 [🔎]
TPLC Last Update: 2019-04-02 20:45:40

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