Exophthalmometer

Device Code: 4200

Product Code(s): HLS

Device Classification Information

Device Type ID4200
Device NameExophthalmometer
Regulation DescriptionExophthalmometer.
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 Number886.1270 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHLS
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4200
DeviceExophthalmometer
Product CodeHLS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionExophthalmometer.
CFR Regulation Number886.1270 [🔎]
TPLC Last Update: 2019-04-02 20:44:38

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