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FDA 510(k)

峰值流量計

K 號:K203196 · 2021-05-26

決定日期2021-05-26
產品代碼BZH
諮詢委員會AN
決定相當於

器材摘要

Peak flow meter is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sonmol Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K203196. 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 Peak flow meter?

Peak flow meter is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Shanghai Sonmol Medical Equipment Co., Ltd.. The 510(k) number is K203196.

When did Peak flow meter receive FDA 510(k) clearance?

Peak flow meter received FDA 510(k) clearance on 2021-05-26, under 510(k) number K203196.

Who is the listed applicant for Peak flow meter?

The FDA 510(k) record lists Shanghai Sonmol Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Peak flow meter?

The FDA product code for Peak flow meter is BZH.

相關臨床試驗

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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。

官方來源

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