FDA 510(k)

헤파팻-에이이

K-번호: K201039 · 2020-12-07

신청자Resonance Health Analysis Services Pty, Ltd.

결정일2020-12-07

제품 코드LNH

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

결정대체적으로 동일

기기 요약

HepaFat-AI is the device name listed in this FDA 510(k) record. The listed applicant is Resonance Health Analysis Services Pty, Ltd.. It received FDA 510(k) clearance on 2020-12-07 under 510(k) number K201039. 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 HepaFat-AI?

HepaFat-AI is a medical device that received FDA 510(k) clearance on 2020-12-07. The listed applicant is Resonance Health Analysis Services Pty, Ltd.. The 510(k) number is K201039.

When did HepaFat-AI receive FDA 510(k) clearance?

HepaFat-AI received FDA 510(k) clearance on 2020-12-07, under 510(k) number K201039.

Who is the listed applicant for HepaFat-AI?

The FDA 510(k) record lists Resonance Health Analysis Services Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HepaFat-AI?

The FDA product code for HepaFat-AI is LNH.

Resonance Health Analysis Services Pty, Ltd.를 신청인으로 등재한 기타 기록

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