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FDA 510(k)

BD Intelliport 系統; BD Intelliport 閱讀器 (516230); BD Intelliport 感應器 (516229); BD Intelliport 網關 (516232); BD Intelliport 裝置 (516233); BD Intelliport 充電器 (516231)

K 號：K243062 · 2025-06-20

申請人Becton Dickinson
決定日期2025-06-20
產品代碼PHC
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K243062. The device is classified under product code PHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)?

BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Becton Dickinson. The 510(k) number is K243062.

When did BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) receive FDA 510(k) clearance?

BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) received FDA 510(k) clearance on 2025-06-20, under 510(k) number K243062.

Who is the listed applicant for BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)?

The FDA 510(k) record lists Becton Dickinson as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)?

The FDA product code for BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) is PHC.

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