FDA 510(k)

溫度感測探針 (ABL-18TP20)

K 號：K240784 · 2024-05-29

決定日期2024-05-29

產品代碼NEY

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

Temperature Sensor Probe (ABL-18TP20) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-05-29 under 510(k) number K240784. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Temperature Sensor Probe (ABL-18TP20)?

Temperature Sensor Probe (ABL-18TP20) is a medical device that received FDA 510(k) clearance on 2024-05-29. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K240784.

When did Temperature Sensor Probe (ABL-18TP20) receive FDA 510(k) clearance?

Temperature Sensor Probe (ABL-18TP20) received FDA 510(k) clearance on 2024-05-29, under 510(k) number K240784.

Who is the listed applicant for Temperature Sensor Probe (ABL-18TP20)?

FDA 510(k) 記錄將 Varian Medical Systems, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Temperature Sensor Probe (ABL-18TP20)?

The FDA product code for Temperature Sensor Probe (ABL-18TP20) is NEY.

其他以 Varian Medical Systems, Inc. 為申請人之記錄

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相關器械（代碼：NEY）

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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官方來源

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