Miris人乳分析儀（HMA）
K 號：K223085 · 2023-09-29
廣告
器材摘要
Miris Human Milk Analyzer (HMA) is the device name listed in this FDA 510(k) record. The listed applicant is Miris AB. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K223085. The device is classified under product code QEI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Miris Human Milk Analyzer (HMA)?
Miris Human Milk Analyzer (HMA) is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Miris AB. The 510(k) number is K223085.
When did Miris Human Milk Analyzer (HMA) receive FDA 510(k) clearance?
Miris Human Milk Analyzer (HMA) received FDA 510(k) clearance on 2023-09-29, under 510(k) number K223085.
Who is the listed applicant for Miris Human Milk Analyzer (HMA)?
The FDA 510(k) record lists Miris AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Miris Human Milk Analyzer (HMA)?
The FDA product code for Miris Human Milk Analyzer (HMA) is QEI.
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。
相關器械（代碼：QEI）
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。
廣告