FDA 510(k)

ESOTEST MULTI 食道温度プローブおよび温度監視システム

K番号: K180047 · 2018-11-08

決定日2018-11-08

製品コードFLL

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

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 2018-11-08 under 510(k) number K180047. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

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 2018-11-08. The listed applicant is Fiab Spa. The 510(k) number is K180047.

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 2018-11-08, under 510(k) number K180047.

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.

申請者としてFiab Spaを記載するその他の記録

K192210ESOTEST MULTI 食道温度プローブおよび温度監視システム

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