FDA 510(k)

EVA（強化視覚評価）システム

K番号: K161871 · 2016-12-19

決定日2016-12-19

製品コードHEX

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Substantially Equivalent

医療機器の概要

EVA (Enhanced Visual Assessment) System is the device name listed in this FDA 510(k) record. The listed applicant is Mobileodt , Ltd.. It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K161871. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the EVA (Enhanced Visual Assessment) System?

EVA (Enhanced Visual Assessment) System is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Mobileodt , Ltd.. The 510(k) number is K161871.

When did EVA (Enhanced Visual Assessment) System receive FDA 510(k) clearance?

EVA (Enhanced Visual Assessment) System received FDA 510(k) clearance on 2016-12-19, under 510(k) number K161871.

Who is the listed applicant for EVA (Enhanced Visual Assessment) System?

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

What is the FDA product code for EVA (Enhanced Visual Assessment) System?

The FDA product code for EVA (Enhanced Visual Assessment) System is HEX.

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EVA（強化視覚評価）システム

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：HEX）

公式ソース