FDA 510(k)

スクリンブラー治療技術（モデルST-5A）

K番号: K201458 · 2020-12-23

申請者Delta International Services & Logistics S.R.L

決定日2020-12-23

製品コードGZJ

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

Scrambler Therapy Technology (Model ST-5A) is the device name listed in this FDA 510(k) record. The listed applicant is Delta International Services & Logistics S.R.L. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K201458. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Scrambler Therapy Technology (Model ST-5A)?

Scrambler Therapy Technology (Model ST-5A) is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Delta International Services & Logistics S.R.L. The 510(k) number is K201458.

When did Scrambler Therapy Technology (Model ST-5A) receive FDA 510(k) clearance?

Scrambler Therapy Technology (Model ST-5A) received FDA 510(k) clearance on 2020-12-23, under 510(k) number K201458.

Who is the listed applicant for Scrambler Therapy Technology (Model ST-5A)?

The FDA 510(k) record lists Delta International Services & Logistics S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Scrambler Therapy Technology (Model ST-5A)?

The FDA product code for Scrambler Therapy Technology (Model ST-5A) is GZJ.

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スクリンブラー治療技術（モデルST-5A）

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：GZJ）

公式ソース