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FDA 510(k)

醫療設備註冊文本翻譯（zh-TW）： SteriTrak

K 號：K203605 · 2021-04-23

申請人Arbutus Medical, Inc.
決定日期2021-04-23
產品代碼JEC
諮詢委員會或
決定相當於

器材摘要

SteriTrak is the device name listed in this FDA 510(k) record. The listed applicant is Arbutus Medical, Inc.. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K203605. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SteriTrak?

SteriTrak is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Arbutus Medical, Inc.. The 510(k) number is K203605.

When did SteriTrak receive FDA 510(k) clearance?

SteriTrak received FDA 510(k) clearance on 2021-04-23, under 510(k) number K203605.

Who is the listed applicant for SteriTrak?

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

What is the FDA product code for SteriTrak?

The FDA product code for SteriTrak is JEC.

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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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