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FDA 510(k)

Comarch e-Care 平臺

K 號：K181248 · 2018-10-22

申請人Comarch Healthcare SA
決定日期2018-10-22
產品代碼DRG
諮詢委員會履歷
決定相當於

器材摘要

Comarch e-Care Platform is the device name listed in this FDA 510(k) record. The listed applicant is Comarch Healthcare SA. It received FDA 510(k) clearance on 2018-10-22 under 510(k) number K181248. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Comarch e-Care Platform?

Comarch e-Care Platform is a medical device that received FDA 510(k) clearance on 2018-10-22. The listed applicant is Comarch Healthcare SA. The 510(k) number is K181248.

When did Comarch e-Care Platform receive FDA 510(k) clearance?

Comarch e-Care Platform received FDA 510(k) clearance on 2018-10-22, under 510(k) number K181248.

Who is the listed applicant for Comarch e-Care Platform?

The FDA 510(k) record lists Comarch Healthcare SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comarch e-Care Platform?

The FDA product code for Comarch e-Care Platform is DRG.

相關臨床試驗

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相關器械（代碼：DRG）

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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