Calibrator, Tonometer

Device Code: 4183

Product Code(s): HLA

Device Classification Information

Device Type ID4183
Device NameCalibrator, Tonometer
Regulation DescriptionTonometer And Accessories.
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)
CFR Regulation Number886.1930 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHLA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID4183
DeviceCalibrator, Tonometer
Product CodeHLA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionTonometer And Accessories.
CFR Regulation Number886.1930 [🔎]
TPLC Last Update: 2019-04-02 20:44:20

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