Stereoscope, Ac-powered

Device Code: 4155

Product Code(s): HJQ

Device Classification Information

Device Type ID4155
Device NameStereoscope, Ac-powered
Regulation DescriptionStereoscope.
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 Number886.1870 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHJQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4155
DeviceStereoscope, Ac-powered
Product CodeHJQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionStereoscope.
CFR Regulation Number886.1870 [🔎]
TPLC Last Update: 2019-04-02 20:43:53

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