FDA 510(k)

SIGNA 헤로

K-번호: K213668 · 2022-01-20

신청자Ge Healthcare (Ge Medical Systems, LLC)

결정일2022-01-20

제품 코드LNH

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

SIGNA Hero is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare (Ge Medical Systems, LLC). It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K213668. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SIGNA Hero?

SIGNA Hero is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Ge Healthcare (Ge Medical Systems, LLC). The 510(k) number is K213668.

When did SIGNA Hero receive FDA 510(k) clearance?

SIGNA Hero received FDA 510(k) clearance on 2022-01-20, under 510(k) number K213668.

Who is the listed applicant for SIGNA Hero?

The FDA 510(k) record lists Ge Healthcare (Ge Medical Systems, LLC) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGNA Hero?

The FDA product code for SIGNA Hero is LNH.

Ge Healthcare (Ge Medical Systems, LLC)를 신청인으로 등재한 기타 기록

K202966SIGNA 아키텍트 K193282SIGNA 프리미어

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