FDA 510(k)

ニューデアトロニクス・ディスポーザブル・ラパロスコピック・電極、非被覆、被覆

K番号: K153265 · 2016-01-05

決定日2016-01-05

製品コードGEI

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

New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated is the device name listed in this FDA 510(k) record. The listed applicant is New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2016-01-05 under 510(k) number K153265. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated?

New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K153265.

When did New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated receive FDA 510(k) clearance?

New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated received FDA 510(k) clearance on 2016-01-05, under 510(k) number K153265.

Who is the listed applicant for New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated?

The FDA 510(k) record lists New Deantronics Taiwan , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated?

The FDA product code for New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated is GEI.

申請者としてNew Deantronics Taiwan , Ltd.を記載するその他の記録

すべての12件のデバイスを表示 →

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。