FDA 510(k)

Pre-Sure

K-번호: K230044 · 2023-05-26

결정일2023-05-26

제품 코드LLZ

자문 위원회RA

결정Substantially Equivalent

기기 요약

Pre-Sure is the device name listed in this FDA 510(k) record. The listed applicant is Lazarus 3D. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K230044. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Pre-Sure?

Pre-Sure is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Lazarus 3D. The 510(k) number is K230044.

When did Pre-Sure receive FDA 510(k) clearance?

Pre-Sure received FDA 510(k) clearance on 2023-05-26, under 510(k) number K230044.

Who is the listed applicant for Pre-Sure?

The FDA 510(k) record lists Lazarus 3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pre-Sure?

The FDA product code for Pre-Sure is LLZ.

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기기 요약

자주 묻는 질문

관련 기기 (코드: LLZ)

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