FDA 510(k)

センテイロ、AuDX、AuDX PRO、センテイロデスクトップ、AuDX PRO フレックス、センテイロアドバンスド、ナブプロワン

K番号: K213345 · 2022-06-22

決定日2022-06-22

製品コードEWO

諮問委員会医用工品規制文書の翻訳この医療機器は、FDA（米国食品医薬品局）の510(k)認証を受けた製品です。PMA（プレマーケティング評価）やNCT（臨床試験登録番号）、PMID（PubMed ID）などの識別情報も提供されています。詳細については、以下のURLをご参照ください。 [URL] 政策：medical-regulatory-v1

決定大幅同等

医療機器の概要

Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE is the device name listed in this FDA 510(k) record. The listed applicant is Path Medical GmbH. It received FDA 510(k) clearance on 2022-06-22 under 510(k) number K213345. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE?

Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE is a medical device that received FDA 510(k) clearance on 2022-06-22. The listed applicant is Path Medical GmbH. The 510(k) number is K213345.

When did Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE receive FDA 510(k) clearance?

Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE received FDA 510(k) clearance on 2022-06-22, under 510(k) number K213345.

Who is the listed applicant for Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE?

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

What is the FDA product code for Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE?

The FDA product code for Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE is EWO.

申請者としてPath Medical GmbHを記載するその他の記録

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