Apparatus, Vestibular Analysis

Device Code: 1658

Product Code(s): LXV

Device Classification Information

Device Type ID1658
Device NameApparatus, Vestibular Analysis
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 CodeLXV
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1658
DeviceApparatus, Vestibular Analysis
Product CodeLXV
TPLC Last Update: 2019-04-02 19:57:14

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