FDA 510(k)

FLC 카파, FLC 라마, FLC 제어 레벨 1, FLC 제어 레벨 2

K-번호: K210623 · 2022-11-18

신청자Sebia

결정일2022-11-18

제품 코드DFH

자문 위원회IM

결정Substantially Equivalent

기기 요약

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K210623. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2?

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Sebia. The 510(k) number is K210623.

When did FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 receive FDA 510(k) clearance?

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 received FDA 510(k) clearance on 2022-11-18, under 510(k) number K210623.

Who is the listed applicant for FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2?

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

What is the FDA product code for FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2?

The FDA product code for FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 is DFH.

Sebia를 신청인으로 등재한 기타 기록

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