Ophthalmoscopes, Replacement Batteries, Hand-held

Device Code: 4353

Product Code(s): MSG

Device Classification Information

Device Type ID4353
Device NameOphthalmoscopes, Replacement Batteries, Hand-held
Regulation DescriptionOphthalmoscope.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Contact Lenses And Retinal Devices Branch (CLRD)
Submission Type510(K) Exempt
CFR Regulation Number886.1570 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMSG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4353
DeviceOphthalmoscopes, Replacement Batteries, Hand-held
Product CodeMSG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionOphthalmoscope.
CFR Regulation Number886.1570 [🔎]
TPLC Last Update: 2019-04-02 20:47:29

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