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FDA 510(k)

RFID Localization System

K-Number: K190932 · 2019-09-13

ApplicantHealth Beacons, Inc.
Decision Date2019-09-13
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RFID Localization System is a medical device manufactured by Health Beacons, Inc.. It received FDA 510(k) clearance on 2019-09-13 under approval number K190932. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RFID Localization System?

RFID Localization System is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Health Beacons, Inc.. The 510(k) number is K190932.

When was RFID Localization System approved by the FDA?

RFID Localization System received FDA 510(k) clearance on 2019-09-13, under approval number K190932.

What company makes RFID Localization System?

RFID Localization System is manufactured by Health Beacons, Inc..

What is the FDA product code for RFID Localization System?

The FDA product code for RFID Localization System is NEU.

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Other Devices by Health Beacons, Inc.

K163667RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) K1816925cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) K193189RFID Localization System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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