FDA 510(k)

マックスモアスパイン双極電極

K番号: K211173 · 2022-06-23

決定日2022-06-23

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

maxmorespine Bipolar Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Hoogland Spine Products, GmbH. It received FDA 510(k) clearance on 2022-06-23 under 510(k) number K211173. 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 maxmorespine Bipolar Electrodes?

maxmorespine Bipolar Electrodes is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Hoogland Spine Products, GmbH. The 510(k) number is K211173.

When did maxmorespine Bipolar Electrodes receive FDA 510(k) clearance?

maxmorespine Bipolar Electrodes received FDA 510(k) clearance on 2022-06-23, under 510(k) number K211173.

Who is the listed applicant for maxmorespine Bipolar Electrodes?

The FDA 510(k) record lists Hoogland Spine Products, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for maxmorespine Bipolar Electrodes?

The FDA product code for maxmorespine Bipolar Electrodes is GEI.

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マックスモアスパイン双極電極

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GEI）

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