FDA 510(k)

STERIZONE 消毒器

K 號：K153689 · 2016-06-30

決定日期2016-06-30

產品代碼PJJ

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

STERIZONE Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Tso3, Inc.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K153689. The device is classified under product code PJJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STERIZONE Sterilizer?

STERIZONE Sterilizer is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Tso3, Inc.. The 510(k) number is K153689.

When did STERIZONE Sterilizer receive FDA 510(k) clearance?

STERIZONE Sterilizer received FDA 510(k) clearance on 2016-06-30, under 510(k) number K153689.

Who is the listed applicant for STERIZONE Sterilizer?

The FDA 510(k) record lists Tso3, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERIZONE Sterilizer?

The FDA product code for STERIZONE Sterilizer is PJJ.

其他以 Tso3, 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。

K190260STERIZONE® VP4 消毒器 K172191STERIZONE VP4 消毒器 K173694STERIZONE VP4 消毒器

相關器械（代碼：PJJ）

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。

K190260STERIZONE® VP4 消毒器Tso3, Inc.K172191STERIZONE VP4 消毒器Tso3, Inc.K173694STERIZONE VP4 消毒器Tso3, Inc.K153392STERIZONE VP4 消毒器Ts03, Inc.

官方來源

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