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FDA 510(k)

RFID定位系统-定位器读取器，RFID定位系统-定位器手术探头，RFID定位系统-定位器手术探头（5件装），RFID定位系统-标签应用器，RFID定位系统 -标签应用器（10件装）

K号: K163667 · 2017-04-28

申请人Health Beacons, Inc.
决定日期2017-04-28
产品代码PBY
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

RFID 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) 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 2017-04-28 under 510(k) number K163667. The device is classified under product code PBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RFID 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)?

RFID 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) is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Health Beacons, Inc.. The 510(k) number is K163667.

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

RFID 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) received FDA 510(k) clearance on 2017-04-28, under 510(k) number K163667.

Who is the listed applicant for RFID 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)?

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- 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)?

The FDA product code for RFID 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) is PBY.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Health Beacons, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K193189RFID定位系统K190932RFID定位系统K1816925cm 标签应用器，7cm 标签应用器，10cm 标签应用器，5cm 标签应用器（10件装），7cm 标签应用器（10件装），10cm 标签应用器（10件装），LOCalizer 外科探针，LOCalizer 外科探针（5件装）

相关器械（代码：PBY）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K223682Sirius Pintuition Seed, Sirius Pintuition 探头, Sirius Pintuition 基础单元Sirius Medical Systems B.V.K222643Sirius Pintuition Seed, Sirius Pintuition 探头, Sirius Pintuition 基础单元Sirius Medical Systems B.V.K200734Sirius Pintuition Seed, Sirius Pintuition 探头, Sirius Pintuition 基础单元Sirius Medical Systems B.V.K163541Magseed磁标记系统Endomagnetics Ltd.,K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,

官方来源

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