FDA 510(k)

Applied Medical ラパロスクリーニングラインカッター

K番号: K190331 · 2019-11-22

申請者Applied Medical Resources Corporation

決定日2019-11-22

製品コードGDW

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Applied Medical Laparoscopic Linear Cutter is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K190331. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Applied Medical Laparoscopic Linear Cutter?

Applied Medical Laparoscopic Linear Cutter is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K190331.

When did Applied Medical Laparoscopic Linear Cutter receive FDA 510(k) clearance?

Applied Medical Laparoscopic Linear Cutter received FDA 510(k) clearance on 2019-11-22, under 510(k) number K190331.

Who is the listed applicant for Applied Medical Laparoscopic Linear Cutter?

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

What is the FDA product code for Applied Medical Laparoscopic Linear Cutter?

The FDA product code for Applied Medical Laparoscopic Linear Cutter is GDW.

申請者としてApplied Medical Resources Corporationを記載するその他の記録

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公式ソース

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