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FDA 510(k)

Kem醫療無鉛化學指示器，用於蒸氣消毒

K 號：K241836 · 2024-09-30

申請人Kem Medical Products Corporation
決定日期2024-09-30
產品代碼JOJ
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

Kem Medical Lead-free Chemical Indicators for Steam Sterilization is the device name listed in this FDA 510(k) record. The listed applicant is Kem Medical Products Corporation. It received FDA 510(k) clearance on 2024-09-30 under 510(k) number K241836. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kem Medical Lead-free Chemical Indicators for Steam Sterilization?

Kem Medical Lead-free Chemical Indicators for Steam Sterilization is a medical device that received FDA 510(k) clearance on 2024-09-30. The listed applicant is Kem Medical Products Corporation. The 510(k) number is K241836.

When did Kem Medical Lead-free Chemical Indicators for Steam Sterilization receive FDA 510(k) clearance?

Kem Medical Lead-free Chemical Indicators for Steam Sterilization received FDA 510(k) clearance on 2024-09-30, under 510(k) number K241836.

Who is the listed applicant for Kem Medical Lead-free Chemical Indicators for Steam Sterilization?

The FDA 510(k) record lists Kem Medical Products Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kem Medical Lead-free Chemical Indicators for Steam Sterilization?

The FDA product code for Kem Medical Lead-free Chemical Indicators for Steam Sterilization is JOJ.

相關臨床試驗

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：JOJ）

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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