Stimulator, Caloric-water

Device Code: 1462

Product Code(s): ETP

Device Classification Information

Device Type ID1462
Device NameStimulator, Caloric-water
Regulation DescriptionAir Or Water Caloric Stimulator.
Regulation Medical SpecialtyEar Nose & Throat
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) Exempt
CFR Regulation Number874.1800 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeETP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1462
DeviceStimulator, Caloric-water
Product CodeETP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionAir Or Water Caloric Stimulator.
CFR Regulation Number874.1800 [🔎]
TPLC Last Update: 2019-04-02 19:54:28

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