FDA 510(k)

SPiN Vision Video Bronchoscope System

K番号: K202346 · 2021-02-19

決定日2021-02-19

製品コードEOQ

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Substantially Equivalent

医療機器の概要

SPiN Vision Video Bronchoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Veran Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K202346. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SPiN Vision Video Bronchoscope System?

SPiN Vision Video Bronchoscope System is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Veran Medical Technologies, Inc.. The 510(k) number is K202346.

When did SPiN Vision Video Bronchoscope System receive FDA 510(k) clearance?

SPiN Vision Video Bronchoscope System received FDA 510(k) clearance on 2021-02-19, under 510(k) number K202346.

Who is the listed applicant for SPiN Vision Video Bronchoscope System?

The FDA 510(k) record lists Veran Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPiN Vision Video Bronchoscope System?

The FDA product code for SPiN Vision Video Bronchoscope System is EOQ.

申請者としてVeran Medical Technologies, Inc.を記載するその他の記録

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公式ソース

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