FDA 510(k)

ECMT-100 WMD 医療設備規範文本翻譯： ECMT-100 WMD 医療設備規範文本

K 號：K253521 · 2026-06-18

決定日期2026-06-18

產品代碼KGN

決定相當於

器材摘要

ECMT-100 WMD is the device name listed in this FDA 510(k) record. The listed applicant is Ecm Therapeutics, Inc.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253521. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the ECMT-100 WMD?

ECMT-100 WMD is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Ecm Therapeutics, Inc.. The 510(k) number is K253521.

When did ECMT-100 WMD receive FDA 510(k) clearance?

ECMT-100 WMD received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253521.

Who is the listed applicant for ECMT-100 WMD?

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

What is the FDA product code for ECMT-100 WMD?

The FDA product code for ECMT-100 WMD is KGN.

相關器械（代碼：KGN）

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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