Stand, Instrument, Ophthalmic, Battery Powered

Device Code: 4387

Product Code(s): NOI

Definition: AC-powered Or Non-powered Device Intended To Store Ophthalmic Instruments In A Readily Accessible Position.

Device Classification Information

Device Type ID4387
Device NameStand, Instrument, Ophthalmic, Battery Powered
Regulation DescriptionOphthalmic Instrument Stand.
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 Number886.1860 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNOI
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4387
DeviceStand, Instrument, Ophthalmic, Battery Powered
Product CodeNOI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOphthalmic Instrument Stand.
CFR Regulation Number886.1860 [🔎]
TPLC Last Update: 2019-04-02 20:48:10

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