FDA 510(k)

使い捨て同心針電極、使い捨て単極針電極、使い捨てEP針電極、使い捨て皮下注射針電極

K番号: K152984 · 2016-06-03

決定日2016-06-03

製品コードIKT

諮問委員会PM 以下は、提供された医療機器規制テキストの日本語訳です。 --- ### 規制文書 **製品名:** [製品名] **会社名:** [会社名] この医療機器は、米国食品医薬品局（FDA）に登録された製品です。 **許可番号:** [許可番号] **510(k)番号:** [510(k)番号] **PMA番号:** [PMA番号] **NCT番号:** [NCT番号] **PMID番号:** [PMID番号] **URL:** [URL] ### 規制ポリシー **ポリシー:** medical-regulatory-v1 --- **注意:** この翻訳は、原文の内容を正確に反映するために行われましたが、法的文書としての正式な翻訳ではありません。

決定大幅同等

医療機器の概要

Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Bio Protech, Inc.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K152984. The device is classified under product code IKT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes?

Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Bio Protech, Inc.. The 510(k) number is K152984.

When did Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes receive FDA 510(k) clearance?

Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152984.

Who is the listed applicant for Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes?

The FDA 510(k) record lists Bio Protech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes?

The FDA product code for Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes is IKT.

申請者としてBio Protech, Inc.を記載するその他の記録

K192035EvaQMax煙排出システム K153019disposable adhesive surface electrodes, disposable/reusable cup electrodes

公式ソース

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