FDA 510(k)

Hudson RCI 水熱 III Plus 外置可調節電熱器 (050-14)

K 號：K223100 · 2023-06-27

決定日期2023-06-27

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2023-06-27 under 510(k) number K223100. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)?

Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) is a medical device that received FDA 510(k) clearance on 2023-06-27. The listed applicant is Medline Industries, Inc.. The 510(k) number is K223100.

When did Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) receive FDA 510(k) clearance?

Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) received FDA 510(k) clearance on 2023-06-27, under 510(k) number K223100.

Who is the listed applicant for Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)?

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

What is the FDA product code for Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)?

The FDA product code for Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) is CAF.

其他以 Medline Industries, 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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