Rack, Skiascopic

Device Code: 4210

Product Code(s): HMH

Device Classification Information

Device Type ID4210
Device NameRack, Skiascopic
Regulation DescriptionSkiascopic Rack.
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 Number886.1750 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHMH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4210
DeviceRack, Skiascopic
Product CodeHMH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSkiascopic Rack.
CFR Regulation Number886.1750 [🔎]
TPLC Last Update: 2019-04-02 20:44:50

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