FDA 510(k)

LM-9300 플러스 암석분해기

K-번호: K213772 · 2023-01-19

결정일2023-01-19

제품 코드LNS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

LM-9300 Plus Lithotripter is the device name listed in this FDA 510(k) record. The listed applicant is Lite-Med, Inc.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K213772. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the LM-9300 Plus Lithotripter?

LM-9300 Plus Lithotripter is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Lite-Med, Inc.. The 510(k) number is K213772.

When did LM-9300 Plus Lithotripter receive FDA 510(k) clearance?

LM-9300 Plus Lithotripter received FDA 510(k) clearance on 2023-01-19, under 510(k) number K213772.

Who is the listed applicant for LM-9300 Plus Lithotripter?

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

What is the FDA product code for LM-9300 Plus Lithotripter?

The FDA product code for LM-9300 Plus Lithotripter is LNS.

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LM-9300 플러스 암석분해기

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LNS)

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