FDA 510(k)

M-Biopsy 半自動バイオプシー機器 M-Biopsy 同軸内視鏡針 for Sem

K番号: K161409 · 2016-08-02

決定日2016-08-02

製品コードKNW

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem is the device name listed in this FDA 510(k) record. The listed applicant is Mermaid Medical A/S. It received FDA 510(k) clearance on 2016-08-02 under 510(k) number K161409. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem?

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem is a medical device that received FDA 510(k) clearance on 2016-08-02. The listed applicant is Mermaid Medical A/S. The 510(k) number is K161409.

When did M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem receive FDA 510(k) clearance?

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem received FDA 510(k) clearance on 2016-08-02, under 510(k) number K161409.

Who is the listed applicant for M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem?

The FDA 510(k) record lists Mermaid Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem?

The FDA product code for M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem is KNW.

公式ソース

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M-Biopsy 半自動バイオプシー機器 M-Biopsy 同軸内視鏡針 for Sem

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：KNW）

公式ソース