Instrument, Measuring, Stereopsis

Device Code: 4184

Product Code(s): HLC

Device Classification Information

Device Type ID4184
Device NameInstrument, Measuring, Stereopsis
Regulation DescriptionStereopsis Measuring Instrument.
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 Number886.1460 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHLC
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4184
DeviceInstrument, Measuring, Stereopsis
Product CodeHLC
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionStereopsis Measuring Instrument.
CFR Regulation Number886.1460 [🔎]
TPLC Last Update: 2019-04-02 20:44:21

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