FDA 510(k)

IOB 體溫管理系統

K 號：K231596 · 2023-06-30

決定日期2023-06-30

產品代碼DWJ

諮詢委員會履歷

決定相當於

器材摘要

IOB Temperature Management System is the device name listed in this FDA 510(k) record. The listed applicant is Iob Medical, Inc.. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K231596. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IOB Temperature Management System?

IOB Temperature Management System is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Iob Medical, Inc.. The 510(k) number is K231596.

When did IOB Temperature Management System receive FDA 510(k) clearance?

IOB Temperature Management System received FDA 510(k) clearance on 2023-06-30, under 510(k) number K231596.

Who is the listed applicant for IOB Temperature Management System?

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

What is the FDA product code for IOB Temperature Management System?

The FDA product code for IOB Temperature Management System is DWJ.

其他以 Iob Medical, 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。

K232638過濾流加熱毯 K221669IOB加熱毯 K201896ivi N3003 外科口罩，ivi N6006 外科口罩 K190221IOB加熱毯 K162679IOB 體溫管理系統

相關器械（代碼：DWJ）

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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