INNOVISION-P5
K 號：K250750 · 2025-07-18
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器材摘要
INNOVISION-P5 is the device name listed in this FDA 510(k) record. The listed applicant is Dk Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K250750. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the INNOVISION-P5?
INNOVISION-P5 is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Dk Medical Systems Co., Ltd.. The 510(k) number is K250750.
When did INNOVISION-P5 receive FDA 510(k) clearance?
INNOVISION-P5 received FDA 510(k) clearance on 2025-07-18, under 510(k) number K250750.
Who is the listed applicant for INNOVISION-P5?
The FDA 510(k) record lists Dk Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for INNOVISION-P5?
The FDA product code for INNOVISION-P5 is IZL.
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其他以 Dk Medical Systems Co., Ltd. 為申請人之記錄
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。
相關器械（代碼：IZL）
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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