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FDA 510(k)

VitaloJAK 诊所(型號 7100)

K 號:K253293 · 2025-12-03

決定日期2025-12-03
產品代碼DSH
諮詢委員會履歷
決定相當於

器材摘要

VitaloJAK Clinic (Model 7100) is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph , Ltd.. It received FDA 510(k) clearance on 2025-12-03 under 510(k) number K253293. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VitaloJAK Clinic (Model 7100)?

VitaloJAK Clinic (Model 7100) is a medical device that received FDA 510(k) clearance on 2025-12-03. The listed applicant is Vitalograph , Ltd.. The 510(k) number is K253293.

When did VitaloJAK Clinic (Model 7100) receive FDA 510(k) clearance?

VitaloJAK Clinic (Model 7100) received FDA 510(k) clearance on 2025-12-03, under 510(k) number K253293.

Who is the listed applicant for VitaloJAK Clinic (Model 7100)?

The FDA 510(k) record lists Vitalograph , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitaloJAK Clinic (Model 7100)?

The FDA product code for VitaloJAK Clinic (Model 7100) is DSH.

相關臨床試驗

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:DSH)

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。

官方來源

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