Makani Science™ 呼吸監測系統
K 號：K233953 · 2025-03-28
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器材摘要
Makani Science™ Respiration Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Makani Science, Inc.. It received FDA 510(k) clearance on 2025-03-28 under 510(k) number K233953. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Makani Science™ Respiration Monitoring System?
Makani Science™ Respiration Monitoring System is a medical device that received FDA 510(k) clearance on 2025-03-28. The listed applicant is Makani Science, Inc.. The 510(k) number is K233953.
When did Makani Science™ Respiration Monitoring System receive FDA 510(k) clearance?
Makani Science™ Respiration Monitoring System received FDA 510(k) clearance on 2025-03-28, under 510(k) number K233953.
Who is the listed applicant for Makani Science™ Respiration Monitoring System?
The FDA 510(k) record lists Makani Science, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Makani Science™ Respiration Monitoring System?
The FDA product code for Makani Science™ Respiration Monitoring System is BZQ.
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相關器械（代碼：BZQ）
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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