CARDIPIA ECG / 模型：CARDIPIA400H、CARDIPIA800H
K 號：K230834 · 2023-11-21
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器材摘要
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H is the device name listed in this FDA 510(k) record. The listed applicant is Trismed Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K230834. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H?
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Trismed Co., Ltd.. The 510(k) number is K230834.
When did CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H receive FDA 510(k) clearance?
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H received FDA 510(k) clearance on 2023-11-21, under 510(k) number K230834.
Who is the listed applicant for CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H?
The FDA 510(k) record lists Trismed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H?
The FDA product code for CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H is DPS.
相關臨床試驗
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相關器械（代碼：DPS）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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