FDA 510(k)

disposable 半自動バイオプシー機器

K番号: K212820 · 2022-07-06

申請者Suzhou Leapmed Healthcare Corporation

決定日2022-07-06

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

Disposable Semi Automatic Biopsy Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Leapmed Healthcare Corporation. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K212820. 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 Disposable Semi Automatic Biopsy Instrument?

Disposable Semi Automatic Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is Suzhou Leapmed Healthcare Corporation. The 510(k) number is K212820.

When did Disposable Semi Automatic Biopsy Instrument receive FDA 510(k) clearance?

Disposable Semi Automatic Biopsy Instrument received FDA 510(k) clearance on 2022-07-06, under 510(k) number K212820.

Who is the listed applicant for Disposable Semi Automatic Biopsy Instrument?

The FDA 510(k) record lists Suzhou Leapmed Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Semi Automatic Biopsy Instrument?

The FDA product code for Disposable Semi Automatic Biopsy Instrument is KNW.

申請者としてSuzhou Leapmed Healthcare Corporationを記載するその他の記録

K212819disposableバイオプシー充填針 K212822使い捨てコアックスアルバイス針 K212284disposable automatic core biopsy instrument

公式ソース

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