FDA 510(k)

エピックス電気外科プローブおよび煙吸引装置

K番号: K171684 · 2017-08-07

申請者Applied Medical Resources Corporation

決定日2017-08-07

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

Epix Electrosurgical Probe with Smoke Evacuation is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2017-08-07 under 510(k) number K171684. 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 Epix Electrosurgical Probe with Smoke Evacuation?

Epix Electrosurgical Probe with Smoke Evacuation is a medical device that received FDA 510(k) clearance on 2017-08-07. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K171684.

When did Epix Electrosurgical Probe with Smoke Evacuation receive FDA 510(k) clearance?

Epix Electrosurgical Probe with Smoke Evacuation received FDA 510(k) clearance on 2017-08-07, under 510(k) number K171684.

Who is the listed applicant for Epix Electrosurgical Probe with Smoke Evacuation?

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

What is the FDA product code for Epix Electrosurgical Probe with Smoke Evacuation?

The FDA product code for Epix Electrosurgical Probe with Smoke Evacuation is GEI.

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