NRV

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Implantable Radio Frequency Transponder System

Device class

Class II (moderate risk)

Regulation

21 CFR 880.6300

Medical specialty

General Hospital

Flags

Implant

FDA 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 electronic scanner (pocket reader). The microtransponder is a passive device that contains an electronic circuit, which is activated externally by a low-powered radio beam sent by a handheld, battery-powered pocket reader. The microtransponder stores only a unique electronic identification number (id). The id number is used to access a database that provides the implanted person's identity and health information supplied by the patient

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