FDA 510(k)

Surn5 電気外科アルゴンビーム発生装置およびアクセサリー

K番号: K203522 · 2021-02-22

決定日2021-02-22

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

Surn5 Electrosurgical Argon Beam Generator and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Surnic Corporation. It received FDA 510(k) clearance on 2021-02-22 under 510(k) number K203522. 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 Surn5 Electrosurgical Argon Beam Generator and Accessories?

Surn5 Electrosurgical Argon Beam Generator and Accessories is a medical device that received FDA 510(k) clearance on 2021-02-22. The listed applicant is Surnic Corporation. The 510(k) number is K203522.

When did Surn5 Electrosurgical Argon Beam Generator and Accessories receive FDA 510(k) clearance?

Surn5 Electrosurgical Argon Beam Generator and Accessories received FDA 510(k) clearance on 2021-02-22, under 510(k) number K203522.

Who is the listed applicant for Surn5 Electrosurgical Argon Beam Generator and Accessories?

The FDA 510(k) record lists Surnic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surn5 Electrosurgical Argon Beam Generator and Accessories?

The FDA product code for Surn5 Electrosurgical Argon Beam Generator and Accessories is GEI.

申請者としてSurnic Corporationを記載するその他の記録

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