FDA 510(k)

Tuttnauer 水平型機型：4472, 5596, 6690, 66120, 69120 和 69180 高壓蒸汽灭菌器

K 號：K181456 · 2019-07-08

決定日期2019-07-08

產品代碼FLE

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

Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves is the device name listed in this FDA 510(k) record. The listed applicant is Tuttnauer , Ltd.. It received FDA 510(k) clearance on 2019-07-08 under 510(k) number K181456. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves?

Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves is a medical device that received FDA 510(k) clearance on 2019-07-08. The listed applicant is Tuttnauer , Ltd.. The 510(k) number is K181456.

When did Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves receive FDA 510(k) clearance?

Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves received FDA 510(k) clearance on 2019-07-08, under 510(k) number K181456.

Who is the listed applicant for Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves?

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

What is the FDA product code for Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves?

The FDA product code for Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves is FLE.

其他以 Tuttnauer , Ltd. 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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相關器械（代碼：FLE）

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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