Alveoair數位肺功能儀
K 號：K222525 · 2023-08-28
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器材摘要
Alveoair Digital Spirometer is the device name listed in this FDA 510(k) record. The listed applicant is Roundworks Technologies Private Limited. It received FDA 510(k) clearance on 2023-08-28 under 510(k) number K222525. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Alveoair Digital Spirometer?
Alveoair Digital Spirometer is a medical device that received FDA 510(k) clearance on 2023-08-28. The listed applicant is Roundworks Technologies Private Limited. The 510(k) number is K222525.
When did Alveoair Digital Spirometer receive FDA 510(k) clearance?
Alveoair Digital Spirometer received FDA 510(k) clearance on 2023-08-28, under 510(k) number K222525.
Who is the listed applicant for Alveoair Digital Spirometer?
The FDA 510(k) record lists Roundworks Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Alveoair Digital Spirometer?
The FDA product code for Alveoair Digital Spirometer is BZG.
相關臨床試驗
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相關器械（代碼：BZG）
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
在 FDA 資料庫中查看 →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。
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