Locator, Metal, Electronic

Device Code: 4280

Product Code(s): HPM

Device Classification Information

Device Type ID4280
Device NameLocator, Metal, Electronic
Regulation DescriptionElectronic Metal Locator.
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 Number886.4400 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHPM
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 ID4280
DeviceLocator, Metal, Electronic
Product CodeHPM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionElectronic Metal Locator.
CFR Regulation Number886.4400 [🔎]
TPLC Last Update: 2019-04-02 20:46:02

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