FDA 510(k)

Synvitro Hyadase

K番号: K200680 · 2020-07-17

決定日2020-07-17

製品コードMQL

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

Synvitro Hyadase is the device name listed in this FDA 510(k) record. The listed applicant is Origio A/S, A Coopersurgical Company. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K200680. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Synvitro Hyadase?

Synvitro Hyadase is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Origio A/S, A Coopersurgical Company. The 510(k) number is K200680.

When did Synvitro Hyadase receive FDA 510(k) clearance?

Synvitro Hyadase received FDA 510(k) clearance on 2020-07-17, under 510(k) number K200680.

Who is the listed applicant for Synvitro Hyadase?

The FDA 510(k) record lists Origio A/S, A Coopersurgical Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synvitro Hyadase?

The FDA product code for Synvitro Hyadase is MQL.

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Synvitro Hyadase

医療機器の概要

よくある質問

関連する臨床試験

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