FDA 510(k)

カナディ・プラズマ SMART XL-1000 電気外科生成器および付属品

K番号: K192124 · 2019-11-21

決定日2019-11-21

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

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Us Medical Innovations, LLC. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K192124. 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 Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories?

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is Us Medical Innovations, LLC. The 510(k) number is K192124.

When did Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories receive FDA 510(k) clearance?

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories received FDA 510(k) clearance on 2019-11-21, under 510(k) number K192124.

Who is the listed applicant for Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories?

The FDA 510(k) record lists Us Medical Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories?

The FDA product code for Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories is GEI.

申請者としてUs Medical Innovations, LLCを記載するその他の記録

K240297カナディ・ヘリオス・コールドプラズマ™ XL-1000CP™ 消融システム（XL-1000CPSYS）K212736カナディ・フレックスロボウリスト

公式ソース

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