Implantable Radio Frequency Transponder System

Device Code: 2696

Product Code(s): NRV

Definition: An Implantable Microtransponder System Intended To Facilitate Access To Identification And Health Information In Humans. It Is Described As Consisting Of A Small Implantable Electronic Microtransponder, An Insertion Device (introducer), And An Electr

Device Classification Information

Device Type ID2696
Device NameImplantable Radio Frequency Transponder System
Regulation DescriptionImplantable Radiofrequency Transponder System For Patient Identification And Health Information.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(K) Exempt
CFR Regulation Number880.6300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNRV
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2696
DeviceImplantable Radio Frequency Transponder System
Product CodeNRV
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionImplantable Radiofrequency Transponder System For Patient Identification And Health Information.
CFR Regulation Number880.6300 [🔎]
TPLC Last Update: 2019-04-02 20:17:32

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