FDA 510(k)

Tyvek®捲材，供STERLINKTM消毒器使用，CI標記

K 號：K212198 · 2021-10-22

決定日期2021-10-22

產品代碼FRG

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Tyvek(R) Roll with CI for STERLINKTM Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Plasmapp Co,., Ltd.. It received FDA 510(k) clearance on 2021-10-22 under 510(k) number K212198. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tyvek(R) Roll with CI for STERLINKTM Sterilizer?

Tyvek(R) Roll with CI for STERLINKTM Sterilizer is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Plasmapp Co,., Ltd.. The 510(k) number is K212198.

When did Tyvek(R) Roll with CI for STERLINKTM Sterilizer receive FDA 510(k) clearance?

Tyvek(R) Roll with CI for STERLINKTM Sterilizer received FDA 510(k) clearance on 2021-10-22, under 510(k) number K212198.

Who is the listed applicant for Tyvek(R) Roll with CI for STERLINKTM Sterilizer?

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

What is the FDA product code for Tyvek(R) Roll with CI for STERLINKTM Sterilizer?

The FDA product code for Tyvek(R) Roll with CI for STERLINKTM Sterilizer is FRG.

其他以 Plasmapp Co,., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K231169STERLINK plus 過濾器，配備 STERLOAD 盒，Tyvek 卷材，CI 用於 STERLINK 過濾器，Terragene Bionova SCBI (BT96)，Terragene Bionova 閱讀器培養箱 (IC10/20FRLCD，Mini-bio)，Terragene Chemdye (CD42)，Terragene Cintape (CT40)K223025泰維克卷材，供STERLINK消毒器使用 K223015STERLINK™ FPS-15s Plus 消毒器配 STERPACK™ plus 盒 K223023Terragene Bionava SCBI (BT96)，Terragene Bionova Reader Incubators (IC10/20FRLCD、Mini-bio)，Terragene Chemdye (CD42)，Terragene Cintape (CT40)K220345STERLINK mini 高溫滅菌器搭配 STERLOAD mini 載物盒，Tyvek 滑動紙卷 CI 用於 STERLINK 滅菌器，STERLINK 滅菌器滅菌過程指示器；Terragene Bionova SCBI (BT96)，Terragene Bionova 閱讀器培養箱 (IC10/20FRLCD，Mini-Bio)，Terragene Chemdye (CD42)，Terragene Cintape (CT40)K212200STERLINK™ FPS-15s Plus 過濾器，配備 STERLOAD™ 盒

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相關器械（代碼：FRG）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261897HALYARD* ARMOR-FLEX* 過濾包裝帶，配備ASSURE-DRY* 技術；HALYARD* HEAVY-FLEX* 過濾包裝帶，配備ASSURE-DRY* 技術；HALYARD* STANDARD-FLEX* 過濾包裝帶，配備ASSURE-DRY* 技術；HALYARD* H300W 過濾包裝帶，配備ASSURE-DRY* 技術O&M Halyard, Inc.K252823杜卡爾克雷佩紙消毒包覆材Dukal, LLC K253454HALYARD* 一步式* 消毒包材；HALYARD* 快速檢查* 消毒包材；HALYARD* 逐序* 消毒包材；HALYARD* 智能折* 消毒包材O&M Halyard, Inc.K251347消毒袋/卷Sterivic Medical Co., Ltd.K251177自封式消毒袋及卷材Guangdong Maidi Medical Co., Ltd.K250306Chex-All 過濾包及管子Propper Manufacturing Co., Inc.

官方來源

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