FDA 510(k)

ESOTEST MULTI 食道溫度探針及溫度監測系統

K 號：K192210 · 2019-10-10

決定日期2019-10-10

產品代碼FLL

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

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Fiab Spa. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K192210. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System?

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Fiab Spa. The 510(k) number is K192210.

When did ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System receive FDA 510(k) clearance?

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System received FDA 510(k) clearance on 2019-10-10, under 510(k) number K192210.

Who is the listed applicant for ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System?

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

What is the FDA product code for ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System?

The FDA product code for ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System is FLL.

其他以 Fiab Spa 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。

K180047ESOTEST MULTI 食道溫度探針及溫度監測系統

相關器械（代碼：FLL）

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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