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NRVClass II

Implantable Radio Frequency Transponder System

21 CFR 880.6300 / General Hospital
FDA source (opens on fda.gov)

NRV is the FDA product code for Implantable Radio Frequency Transponder System, a class II device type, regulated under 21 CFR 880.6300. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NRV
Device name
Implantable Radio Frequency Transponder System
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
Regulation
21 CFR 880.6300
Device class
Class II
Review panel
General Hospital
Submission type
510(k) exempt
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NRV

By decision year
1 clearance under product code NRV with a decision year between 2004 and 2004, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NRV by decision year
YearClearances
20041

Applicants with the most clearances

Product code NRV
Applicants holding the most 510(k) clearances under product code NRV
ApplicantClearances
Digital Angel Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code