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FDA 510(k)

740 SafeSAT

K 號：K200160 · 2021-02-15

申請人Zoe Medical, Inc.
決定日期2021-02-15
產品代碼MWI
諮詢委員會履歷
決定相當於

器材摘要

740 SafeSAT is the device name listed in this FDA 510(k) record. The listed applicant is Zoe Medical, Inc.. It received FDA 510(k) clearance on 2021-02-15 under 510(k) number K200160. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 740 SafeSAT?

740 SafeSAT is a medical device that received FDA 510(k) clearance on 2021-02-15. The listed applicant is Zoe Medical, Inc.. The 510(k) number is K200160.

When did 740 SafeSAT receive FDA 510(k) clearance?

740 SafeSAT received FDA 510(k) clearance on 2021-02-15, under 510(k) number K200160.

Who is the listed applicant for 740 SafeSAT?

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

What is the FDA product code for 740 SafeSAT?

The FDA product code for 740 SafeSAT is MWI.

相關臨床試驗

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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相關器械（代碼：MWI）

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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