FDA 510(k)

STERLINK™ FPS-15s Plus 消毒器配 STERPACK™ plus 盒

K 號：K223015 · 2023-05-09

決定日期2023-05-09

產品代碼MLR

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

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette 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 2023-05-09 under 510(k) number K223015. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette?

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette is a medical device that received FDA 510(k) clearance on 2023-05-09. The listed applicant is Plasmapp Co,., Ltd.. The 510(k) number is K223015.

When did STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette receive FDA 510(k) clearance?

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette received FDA 510(k) clearance on 2023-05-09, under 510(k) number K223015.

Who is the listed applicant for STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette?

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 STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette?

The FDA product code for STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette is MLR.

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 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)K212198Tyvek®捲材，供STERLINKTM消毒器使用，CI標記 K212193Terragene Bionova SCBI (BT96)，Terragene Bionova 閱讀孵育器 (IC10/20FRLCD、迷你-bio)，Terragene Chemdye (CD42)，Terragene Cintape (CT40)

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相關器械（代碼：MLR）

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。

K252843STERRAD 100NX 消毒系統搭配 ALLClear 技術（10104）Advanced Sterilization Products, Inc.K250802STERRAD® 100NX 高效滅菌器搭配 ALLClear™ 技術（10104）Advanced Sterilization Products, Inc.K231893LOWTEM 晶體 120Lowtem Co., Ltd.K234082STERRAD® 100NX 消毒器搭配 ALLClear™ 技術及 ULTRA GI™ 循環 (10104)；APTIMAX™ 裝置盤適用於 ULTRA GI™ 循環 (011077)Advanced Sterilization Products K233762Stereoscope® 過濾技術系統Ideate Medical, Inc.K233065V-PRO maX 2 低溫消毒系統Steris

官方來源

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