FDA 510(k)

セーフティ・バック・スモークおよび流体吸引器

K番号: K170582 · 2017-04-14

申請者Surgical Technology Laboratories, Inc.

決定日2017-04-14

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

Saf-T-Vac Smoke and Fluid Evacuator is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technology Laboratories, Inc.. It received FDA 510(k) clearance on 2017-04-14 under 510(k) number K170582. 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 Saf-T-Vac Smoke and Fluid Evacuator?

Saf-T-Vac Smoke and Fluid Evacuator is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Surgical Technology Laboratories, Inc.. The 510(k) number is K170582.

When did Saf-T-Vac Smoke and Fluid Evacuator receive FDA 510(k) clearance?

Saf-T-Vac Smoke and Fluid Evacuator received FDA 510(k) clearance on 2017-04-14, under 510(k) number K170582.

Who is the listed applicant for Saf-T-Vac Smoke and Fluid Evacuator?

The FDA 510(k) record lists Surgical Technology Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Saf-T-Vac Smoke and Fluid Evacuator?

The FDA product code for Saf-T-Vac Smoke and Fluid Evacuator is GEI.

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セーフティ・バック・スモークおよび流体吸引器

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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