Cabinet, Instrument, Ac-powered, Ophthalmic

Device Code: 4314

Product Code(s): HRE

Device Classification Information

Device Type ID4314
Device NameCabinet, Instrument, Ac-powered, Ophthalmic
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 CodeHRE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4314
DeviceCabinet, Instrument, Ac-powered, Ophthalmic
Product CodeHRE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOphthalmic Instrument Stand.
CFR Regulation Number886.1860 [🔎]
TPLC Last Update: 2019-04-02 20:46:48

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