truFlex
K 號：K251594 · 2025-08-28
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器材摘要
truFlex is the device name listed in this FDA 510(k) record. The listed applicant is Syrma Johari Medtech Limited. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K251594. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the truFlex?
truFlex is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Syrma Johari Medtech Limited. The 510(k) number is K251594.
When did truFlex receive FDA 510(k) clearance?
truFlex received FDA 510(k) clearance on 2025-08-28, under 510(k) number K251594.
Who is the listed applicant for truFlex?
The FDA 510(k) record lists Syrma Johari Medtech Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for truFlex?
The FDA product code for truFlex is NGX.
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相關器械（代碼：NGX）
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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