FDA 510(k)

DCM (PW-DCM)

K 號：K243513 · 2025-04-16

決定日期2025-04-16

產品代碼LEL

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

DCM (PW-DCM) is the device name listed in this FDA 510(k) record. The listed applicant is Pneumowave, Ltd.. It received FDA 510(k) clearance on 2025-04-16 under 510(k) number K243513. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DCM (PW-DCM)?

DCM (PW-DCM) is a medical device that received FDA 510(k) clearance on 2025-04-16. The listed applicant is Pneumowave, Ltd.. The 510(k) number is K243513.

When did DCM (PW-DCM) receive FDA 510(k) clearance?

DCM (PW-DCM) received FDA 510(k) clearance on 2025-04-16, under 510(k) number K243513.

Who is the listed applicant for DCM (PW-DCM)?

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

What is the FDA product code for DCM (PW-DCM)?

The FDA product code for DCM (PW-DCM) is LEL.

相關器械（代碼：LEL）

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官方來源

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