FDA 510(k)

凝固溶液セットおよび温熱溶液セット

K番号: K233846 · 2024-08-27

決定日2024-08-27

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

決定大幅同等

医療機器の概要

Vitrification Solution Set and Warming Solution Set is the device name listed in this FDA 510(k) record. The listed applicant is Ecmpc, LLC. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K233846. 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 Vitrification Solution Set and Warming Solution Set?

Vitrification Solution Set and Warming Solution Set is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is Ecmpc, LLC. The 510(k) number is K233846.

When did Vitrification Solution Set and Warming Solution Set receive FDA 510(k) clearance?

Vitrification Solution Set and Warming Solution Set received FDA 510(k) clearance on 2024-08-27, under 510(k) number K233846.

Who is the listed applicant for Vitrification Solution Set and Warming Solution Set?

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

What is the FDA product code for Vitrification Solution Set and Warming Solution Set?

The FDA product code for Vitrification Solution Set and Warming Solution Set is MQL.

公式ソース

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凝固溶液セットおよび温熱溶液セット

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：MQL）

公式ソース