FDA 510(k)

ステリティテ・リジッド・リユース可能な消毒容器、メディトレイ製品を使用

K番号: K240898 · 2024-07-31

決定日2024-07-31

製品コードKCT

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

SteriTite rigid reusable sterilization container with MediTray Products is the device name listed in this FDA 510(k) record. The listed applicant is Case Medical. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K240898. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SteriTite rigid reusable sterilization container with MediTray Products?

SteriTite rigid reusable sterilization container with MediTray Products is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Case Medical. The 510(k) number is K240898.

When did SteriTite rigid reusable sterilization container with MediTray Products receive FDA 510(k) clearance?

SteriTite rigid reusable sterilization container with MediTray Products received FDA 510(k) clearance on 2024-07-31, under 510(k) number K240898.

Who is the listed applicant for SteriTite rigid reusable sterilization container with MediTray Products?

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

What is the FDA product code for SteriTite rigid reusable sterilization container with MediTray Products?

The FDA product code for SteriTite rigid reusable sterilization container with MediTray Products is KCT.

公式ソース

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ステリティテ・リジッド・リユース可能な消毒容器、メディトレイ製品を使用

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：KCT）

公式ソース