Tube, Toynbee Diagnostic

Device Code: 1459

Product Code(s): ETK

Device Classification Information

Device Type ID1459
Device NameTube, Toynbee Diagnostic
Regulation DescriptionToynbee Diagnostic Tube.
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 Number874.1925 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeETK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1459
DeviceTube, Toynbee Diagnostic
Product CodeETK
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionToynbee Diagnostic Tube.
CFR Regulation Number874.1925 [🔎]
TPLC Last Update: 2019-04-02 19:54:25

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