FDA 510(k)

ファンギテル STAT

K番号: K191167 · 2019-07-17

決定日2019-07-17

製品コードNQZ

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- MI --- URLや識別子などは原文のままです。

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医療機器の概要

Fungitell STAT is the device name listed in this FDA 510(k) record. The listed applicant is Associates of Cape Cod, Inc.. It received FDA 510(k) clearance on 2019-07-17 under 510(k) number K191167. The device is classified under product code NQZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Fungitell STAT?

Fungitell STAT is a medical device that received FDA 510(k) clearance on 2019-07-17. The listed applicant is Associates of Cape Cod, Inc.. The 510(k) number is K191167.

When did Fungitell STAT receive FDA 510(k) clearance?

Fungitell STAT received FDA 510(k) clearance on 2019-07-17, under 510(k) number K191167.

Who is the listed applicant for Fungitell STAT?

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

What is the FDA product code for Fungitell STAT?

The FDA product code for Fungitell STAT is NQZ.

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