ZywieZ3感測器與膠粘劑
K 號：K252839 · 2026-06-18
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器材摘要
ZywieZ3 Sensor & Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Zywie, Inc.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K252839. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ZywieZ3 Sensor & Adhesive?
ZywieZ3 Sensor & Adhesive is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Zywie, Inc.. The 510(k) number is K252839.
When did ZywieZ3 Sensor & Adhesive receive FDA 510(k) clearance?
ZywieZ3 Sensor & Adhesive received FDA 510(k) clearance on 2026-06-18, under 510(k) number K252839.
Who is the listed applicant for ZywieZ3 Sensor & Adhesive?
The FDA 510(k) record lists Zywie, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ZywieZ3 Sensor & Adhesive?
The FDA product code for ZywieZ3 Sensor & Adhesive is MWJ.
相關臨床試驗
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相關器械（代碼：MWJ）
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
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