RFID Localization System

Marker, Radiographic, Implantable

Health Beacons, Inc.

The following data is part of a premarket notification filed by Health Beacons, Inc. with the FDA for Rfid Localization System.

Pre-market Notification Details

Device IDK193189
510k NumberK193189
Device Name:RFID Localization System
ClassificationMarker, Radiographic, Implantable
Applicant Health Beacons, Inc. 34 Walden St. #753 Concord,  MA  01742
ContactNancy Confrey
CorrespondentFelicia Hosey
R&Q Solutions 2790 Mosside Blvd, Suite 800 Monroeville,  PA  15146
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-19
Decision Date2020-05-06

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