Arthrometer

Device Code: 3820

Product Code(s): LYH

Device Classification Information

Device Type ID3820
Device NameArthrometer
Regulation DescriptionMiniature Pressure Transducer.
Regulation Medical SpecialtyPhysical Medicine
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission Type510(K) Exempt
CFR Regulation Number890.1615 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeLYH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3820
DeviceArthrometer
Product CodeLYH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMiniature Pressure Transducer.
CFR Regulation Number890.1615 [🔎]
TPLC Last Update: 2019-04-02 20:37:31

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.