FDA 510(k)

Breezing醫療設備注意：此翻譯僅針對給定的文本進行翻譯，並未包含完整的翻譯政策說明。如需進一步的翻譯或說明，請提供完整的翻譯政策或相關背景資訊。

K 號：K200076 · 2020-09-25

決定日期2020-09-25

產品代碼BZL

諮詢委員會AN

決定相當於

器材摘要

Breezing Med is the device name listed in this FDA 510(k) record. The listed applicant is Tf Health Co.. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K200076. The device is classified under product code BZL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Breezing Med?

Breezing Med is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Tf Health Co.. The 510(k) number is K200076.

When did Breezing Med receive FDA 510(k) clearance?

Breezing Med received FDA 510(k) clearance on 2020-09-25, under 510(k) number K200076.

Who is the listed applicant for Breezing Med?

The FDA 510(k) record lists Tf Health Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Breezing Med?

The FDA product code for Breezing Med is BZL.

相關器械（代碼：BZL）

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。

K190561NICU V'02Cosmed Nordic Aps

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：BZL）

官方來源