FDA 510(k)

디프이초

K-번호: K242594 · 2025-05-23

결정일2025-05-23

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

DEEPECHO is the device name listed in this FDA 510(k) record. The listed applicant is Deepecho. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K242594. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the DEEPECHO?

DEEPECHO is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is Deepecho. The 510(k) number is K242594.

When did DEEPECHO receive FDA 510(k) clearance?

DEEPECHO received FDA 510(k) clearance on 2025-05-23, under 510(k) number K242594.

Who is the listed applicant for DEEPECHO?

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

What is the FDA product code for DEEPECHO?

The FDA product code for DEEPECHO is IYN.

관련 기기 (코드: IYN)

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관련 기기 (코드: IYN)

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