Hearing Aid, Tactile

Device Code: 1656

Product Code(s): LRA

Device Classification Information

Device Type ID1656
Device NameHearing Aid, Tactile
Review PanelEar Nose & Throat
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Ear, Nose, And Throat Devices Branch (ENTB)
Submission Type510(k)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeLRA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1656
DeviceHearing Aid, Tactile
Product CodeLRA
TPLC Last Update: 2019-04-02 19:57:13

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