Pump, Nebulizer, Electrically Powered

Device Code: 1484

Product Code(s): JPW

Device Classification Information

Device Type ID1484
Device NamePump, Nebulizer, Electrically Powered
Regulation DescriptionEar, Nose, And Throat Drug Administration Device.
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 Number874.5220 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJPW
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1484
DevicePump, Nebulizer, Electrically Powered
Product CodeJPW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEar, Nose, And Throat Drug Administration Device.
CFR Regulation Number874.5220 [🔎]
TPLC Last Update: 2019-04-02 19:54:46

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