FDA 510(k)

単回使用関節鏡電極（ペン付き）

K番号: K170703 · 2018-05-31

申請者Modern Medical Equipment Manufacturing Limited

決定日2018-05-31

製品コードHRX

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

Single Use Arthroscopic Electrode (with Pencil) is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Manufacturing Limited. It received FDA 510(k) clearance on 2018-05-31 under 510(k) number K170703. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Single Use Arthroscopic Electrode (with Pencil)?

Single Use Arthroscopic Electrode (with Pencil) is a medical device that received FDA 510(k) clearance on 2018-05-31. The listed applicant is Modern Medical Equipment Manufacturing Limited. The 510(k) number is K170703.

When did Single Use Arthroscopic Electrode (with Pencil) receive FDA 510(k) clearance?

Single Use Arthroscopic Electrode (with Pencil) received FDA 510(k) clearance on 2018-05-31, under 510(k) number K170703.

Who is the listed applicant for Single Use Arthroscopic Electrode (with Pencil)?

The FDA 510(k) record lists Modern Medical Equipment Manufacturing Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Arthroscopic Electrode (with Pencil)?

The FDA product code for Single Use Arthroscopic Electrode (with Pencil) is HRX.

申請者としてModern Medical Equipment Manufacturing Limitedを記載するその他の記録

K163442一回使用マイクロ電極（金メッキシャフトの銅製）；一回使用マイクロ電極（ステンレスシャフト）K152059disposable general electrode

公式ソース

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