FDA 510(k)

STERLINK™ FPS-15s Plus 過濾器，配備 STERLOAD™ 盒

K 號：K212200 · 2021-10-22

決定日期2021-10-22

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

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM 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 2021-10-22 under 510(k) number K212200. 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 STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette?

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette 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 K212200.

When did STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette receive FDA 510(k) clearance?

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette received FDA 510(k) clearance on 2021-10-22, under 510(k) number K212200.

Who is the listed applicant for STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM 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 STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette?

The FDA product code for STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM 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 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)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。

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官方來源

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