FDA 510(k)

麥可萊數位峰流速計，型號 PF200B (PF200B)

K 號：K253180 · 2026-06-23

決定日期2026-06-23

產品代碼BZH

諮詢委員會AN

決定相當於

器材摘要

Microlife Digital Peak Flow Meter, Model PF200B (PF200B) is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Corporation. It received FDA 510(k) clearance on 2026-06-23 under 510(k) number K253180. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Microlife Digital Peak Flow Meter, Model PF200B (PF200B)?

Microlife Digital Peak Flow Meter, Model PF200B (PF200B) is a medical device that received FDA 510(k) clearance on 2026-06-23. The listed applicant is Microlife Corporation. The 510(k) number is K253180.

When did Microlife Digital Peak Flow Meter, Model PF200B (PF200B) receive FDA 510(k) clearance?

Microlife Digital Peak Flow Meter, Model PF200B (PF200B) received FDA 510(k) clearance on 2026-06-23, under 510(k) number K253180.

Who is the listed applicant for Microlife Digital Peak Flow Meter, Model PF200B (PF200B)?

FDA 510(k) 記錄中將 Microlife Corporation 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Microlife Digital Peak Flow Meter, Model PF200B (PF200B)?

The FDA product code for Microlife Digital Peak Flow Meter, Model PF200B (PF200B) is BZH.

其他以 Microlife Corporation 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。

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相關器械（代碼：BZH）

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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