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FDA 510(k)

RFID 定位系統- 定位讀取器，RFID 定位系統- 定位外科探針，RFID 定位系統- 定位外科探針（5 套裝），RFID 定位系統- 標籤施用器，RFID 定位系統 - 標籤施用器（10 套裝）

K 號：K163667 · 2017-04-28

申請人Health Beacons, Inc.
決定日期2017-04-28
產品代碼PBY
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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其他以 Health Beacons, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：PBY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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