FDA 510(k)

SporView 快速讀取生物指示劑 SteamPlus 測試包

K 號：K181434 · 2018-11-14

申請人Crosstex/Spsmedical, A Division of Cantel Medical

決定日期2018-11-14

產品代碼FRC

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

SporView Rapid Read Biological Indicator SteamPlus Test Pack is the device name listed in this FDA 510(k) record. The listed applicant is Crosstex/Spsmedical, A Division of Cantel Medical. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K181434. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SporView Rapid Read Biological Indicator SteamPlus Test Pack?

SporView Rapid Read Biological Indicator SteamPlus Test Pack is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Crosstex/Spsmedical, A Division of Cantel Medical. The 510(k) number is K181434.

When did SporView Rapid Read Biological Indicator SteamPlus Test Pack receive FDA 510(k) clearance?

SporView Rapid Read Biological Indicator SteamPlus Test Pack received FDA 510(k) clearance on 2018-11-14, under 510(k) number K181434.

Who is the listed applicant for SporView Rapid Read Biological Indicator SteamPlus Test Pack?

The FDA 510(k) record lists Crosstex/Spsmedical, A Division of Cantel Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SporView Rapid Read Biological Indicator SteamPlus Test Pack?

The FDA product code for SporView Rapid Read Biological Indicator SteamPlus Test Pack is FRC.

其他以 Crosstex/Spsmedical, A Division of Cantel Medical 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。

K172432SporView 快速讀取生物指示標

相關器械（代碼：FRC）

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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