FDA 510(k)

バークリーVC-10吸引吸引器システム

K番号: K171440 · 2017-09-29

決定日2017-09-29

製品コードHHI

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

Berkeley VC-10 Vacuum Curettage System is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi. It received FDA 510(k) clearance on 2017-09-29 under 510(k) number K171440. The device is classified under product code HHI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Berkeley VC-10 Vacuum Curettage System?

Berkeley VC-10 Vacuum Curettage System is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Gyrus Acmi. The 510(k) number is K171440.

When did Berkeley VC-10 Vacuum Curettage System receive FDA 510(k) clearance?

Berkeley VC-10 Vacuum Curettage System received FDA 510(k) clearance on 2017-09-29, under 510(k) number K171440.

Who is the listed applicant for Berkeley VC-10 Vacuum Curettage System?

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

What is the FDA product code for Berkeley VC-10 Vacuum Curettage System?

The FDA product code for Berkeley VC-10 Vacuum Curettage System is HHI.

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医療機器の概要

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