Perimeter, Manual

Device Code: 4258

Product Code(s): HON

Device Classification Information

Device Type ID4258
Device NamePerimeter, Manual
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 CodeHON
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4258
DevicePerimeter, Manual
Product CodeHON
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPerimeter.
CFR Regulation Number886.1605 [🔎]
TPLC Last Update: 2019-04-02 20:45:39

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