視覺呼吸
K 號：K261633 · 2026-07-14
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器材摘要
VisuBreath is the device name listed in this FDA 510(k) record. The listed applicant is Affirm Medical Technologies II, LLC. It received FDA 510(k) clearance on 2026-07-14 under 510(k) number K261633. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VisuBreath?
VisuBreath is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Affirm Medical Technologies II, LLC. The 510(k) number is K261633.
When did VisuBreath receive FDA 510(k) clearance?
VisuBreath received FDA 510(k) clearance on 2026-07-14, under 510(k) number K261633.
Who is the listed applicant for VisuBreath?
The FDA 510(k) record lists Affirm Medical Technologies II, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VisuBreath?
The FDA product code for VisuBreath is CCK.
相關臨床試驗
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相關器械（代碼：CCK）
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
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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