FDA 510(k)

EFAI CARDIOSUITE SPECT 心肌灌流靈活工作流程

K 號：K213731 · 2022-05-31

決定日期2022-05-31

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows is the device name listed in this FDA 510(k) record. The listed applicant is Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K213731. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows?

EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K213731.

When did EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows receive FDA 510(k) clearance?

EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows received FDA 510(k) clearance on 2022-05-31, under 510(k) number K213731.

Who is the listed applicant for EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows?

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

What is the FDA product code for EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows?

The FDA product code for EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows is KPS.

其他以 Ever Fortune.Ai, Co., Ltd. 為申請人之記錄

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相關器械（代碼：KPS）

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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