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510(k) K193189

RFID Localization System by Health Beacons, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2020
Date Received
November 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Health Beacons, Inc.

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  • K163667 — RFID Localization System- Localizer Reader, RFID Localization System- Localizer (April 28, 2017)

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