결정일2026-03-04
제품 코드FTC
자문 위원회SU
결정Substantially Equivalent
기기 요약
Klär Lite (RCW-KL1000) is the device name listed in this FDA 510(k) record. The listed applicant is Radcliffe Watts, LLC. It received FDA 510(k) clearance on 2026-03-04 under 510(k) number K253871. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
자주 묻는 질문
What is the Klär Lite (RCW-KL1000)?
Klär Lite (RCW-KL1000) is a medical device that received FDA 510(k) clearance on 2026-03-04. The listed applicant is Radcliffe Watts, LLC. The 510(k) number is K253871.
When did Klär Lite (RCW-KL1000) receive FDA 510(k) clearance?
Klär Lite (RCW-KL1000) received FDA 510(k) clearance on 2026-03-04, under 510(k) number K253871.
Who is the listed applicant for Klär Lite (RCW-KL1000)?
The FDA 510(k) record lists Radcliffe Watts, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Klär Lite (RCW-KL1000)?
The FDA product code for Klär Lite (RCW-KL1000) is FTC.
관련 기기 (코드: FTC)
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
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공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.