FDA 510(k)

Tuttnauer 水平式高压蒸汽灭菌器系列型號：4472、5596、6690、66120

K 號：K221227 · 2022-09-20

決定日期2022-09-20

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 autoclave series model: 4472, 5596, 6690, 66120 is the device name listed in this FDA 510(k) record. The listed applicant is Tuttnauer , Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K221227. 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 autoclave series model: 4472, 5596, 6690, 66120?

Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Tuttnauer , Ltd.. The 510(k) number is K221227.

When did Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 receive FDA 510(k) clearance?

Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 received FDA 510(k) clearance on 2022-09-20, under 510(k) number K221227.

Who is the listed applicant for Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120?

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 autoclave series model: 4472, 5596, 6690, 66120?

The FDA product code for Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 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。

K222608Tuttnauer 預真空蒸汽滅菌器型號 3870HSG 及 3870HSG-WS K213080T-Edge 10, T-Edge 11 K181456Tuttnauer 水平型機型：4472, 5596, 6690, 66120, 69120 和 69180 高壓蒸汽灭菌器

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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