Esthesiometer, Ocular

Device Code: 4143

Product Code(s): HJC

Device Classification Information

Device Type ID4143
Device NameEsthesiometer, Ocular
Regulation DescriptionOcular Esthesiometer.
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 Number886.1040 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHJC
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4143
DeviceEsthesiometer, Ocular
Product CodeHJC
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOcular Esthesiometer.
CFR Regulation Number886.1040 [🔎]
TPLC Last Update: 2019-04-02 20:43:42

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.