FDA 510(k)Braun Aura 9 (6042)
K 號:K261977 · 2026-09-25
決定日期2026-09-25
產品代碼OHT
諮詢委員會SU
決定Substantially Equivalent
器材摘要
Braun Aura 9 (6042) is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K261977. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Braun Aura 9 (6042)?
Braun Aura 9 (6042) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Cyden Limited. The 510(k) number is K261977.
When did Braun Aura 9 (6042) receive FDA 510(k) clearance?
Braun Aura 9 (6042) received FDA 510(k) clearance on 2026-09-25, under 510(k) number K261977.
Who is the listed applicant for Braun Aura 9 (6042)?
The FDA 510(k) record lists Cyden Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Braun Aura 9 (6042)?
The FDA product code for Braun Aura 9 (6042) is OHT.
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其他以 Cyden Limited 為申請人之記錄
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相關器械(代碼:OHT)
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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