Magnet, Ac-powered

Device Code: 4282

Product Code(s): HPO

Device Classification Information

Device Type ID4282
Device NameMagnet, Ac-powered
Regulation DescriptionAC-powered Magnet.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission Type510(K) Exempt
CFR Regulation Number886.4440 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHPO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID4282
DeviceMagnet, Ac-powered
Product CodeHPO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAC-powered Magnet.
CFR Regulation Number886.4440 [🔎]
TPLC Last Update: 2019-04-02 20:46:04

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