FDA 510(k)

Acessa ProVuシステム

K番号: K181124 · 2018-09-28

決定日2018-09-28

製品コードHFG

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

Acessa ProVu System is the device name listed in this FDA 510(k) record. The listed applicant is Acessa Health, Inc.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K181124. The device is classified under product code HFG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Acessa ProVu System?

Acessa ProVu System is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Acessa Health, Inc.. The 510(k) number is K181124.

When did Acessa ProVu System receive FDA 510(k) clearance?

Acessa ProVu System received FDA 510(k) clearance on 2018-09-28, under 510(k) number K181124.

Who is the listed applicant for Acessa ProVu System?

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

What is the FDA product code for Acessa ProVu System?

The FDA product code for Acessa ProVu System is HFG.

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