LFR-260
K-번호: K233295 · 2024-05-31
광고
결정일2024-05-31
제품 코드SBI
자문 위원회의료장비 규제 텍스트 번역
OP
결정Substantially Equivalent
기기 요약
LFR-260 is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Optiks Limited. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K233295. The device is classified under product code SBI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
자주 묻는 질문
What is the LFR-260?
LFR-260 is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Evolution Optiks Limited. The 510(k) number is K233295.
When did LFR-260 receive FDA 510(k) clearance?
LFR-260 received FDA 510(k) clearance on 2024-05-31, under 510(k) number K233295.
Who is the listed applicant for LFR-260?
The FDA 510(k) record lists Evolution Optiks Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LFR-260?
The FDA product code for LFR-260 is SBI.
공식 출처
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광고