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FDA 510(k)

RFID Localization System

K-Number: K193189 · 2020-05-06

ApplicantHealth Beacons, Inc.
Decision Date2020-05-06
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RFID Localization System is the device name listed in this FDA 510(k) record. The listed applicant is Health Beacons, Inc.. It received FDA 510(k) clearance on 2020-05-06 under 510(k) number K193189. 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 2020-05-06. The listed applicant is Health Beacons, Inc.. The 510(k) number is K193189.

When did RFID Localization System receive FDA 510(k) clearance?

RFID Localization System received FDA 510(k) clearance on 2020-05-06, under 510(k) number K193189.

Who is the listed applicant for RFID Localization System?

The FDA 510(k) record lists Health Beacons, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RFID Localization System?

The FDA product code for RFID Localization System is NEU.

Other records listing Health Beacons, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190932RFID Localization SystemK1816925cm 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)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)

Related Devices (Code: NEU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc.

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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