FDA 510(k)

어리포인트 시스템

K-번호: K243891 · 2025-03-26

결정일2025-03-26

제품 코드QPF

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

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기기 요약

EarliPoint System is the device name listed in this FDA 510(k) record. The listed applicant is Earlitec Diagnostics. It received FDA 510(k) clearance on 2025-03-26 under 510(k) number K243891. The device is classified under product code QPF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the EarliPoint System?

EarliPoint System is a medical device that received FDA 510(k) clearance on 2025-03-26. The listed applicant is Earlitec Diagnostics. The 510(k) number is K243891.

When did EarliPoint System receive FDA 510(k) clearance?

EarliPoint System received FDA 510(k) clearance on 2025-03-26, under 510(k) number K243891.

Who is the listed applicant for EarliPoint System?

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

What is the FDA product code for EarliPoint System?

The FDA product code for EarliPoint System is QPF.

Earlitec Diagnostics를 신청인으로 등재한 기타 기록

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