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FDA 510(k)

gke 體外生物指標蒸汽迷你生物記錄器（SCBI）Steri-Record Steam Mini-Bio-Plus

K 號：K163144 · 2017-04-07

申請人Gke-GmbH
決定日期2017-04-07
產品代碼FRC
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

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) is the device name listed in this FDA 510(k) record. The listed applicant is Gke-GmbH. It received FDA 510(k) clearance on 2017-04-07 under 510(k) number K163144. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)?

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) is a medical device that received FDA 510(k) clearance on 2017-04-07. The listed applicant is Gke-GmbH. The 510(k) number is K163144.

When did gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) receive FDA 510(k) clearance?

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) received FDA 510(k) clearance on 2017-04-07, under 510(k) number K163144.

Who is the listed applicant for gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)?

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

What is the FDA product code for gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)?

The FDA product code for gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) is FRC.

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