FDA 510(k)

LOGIQ e

K-번호: K232186 · 2023-11-03

신청자Ge Medical Systems Ultrasound and Primary Care Diagnostic,

결정일2023-11-03

제품 코드IYN

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

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기기 요약

LOGIQ e is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostic,. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K232186. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the LOGIQ e?

LOGIQ e is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostic,. The 510(k) number is K232186.

When did LOGIQ e receive FDA 510(k) clearance?

LOGIQ e received FDA 510(k) clearance on 2023-11-03, under 510(k) number K232186.

Who is the listed applicant for LOGIQ e?

The FDA 510(k) record lists Ge Medical Systems Ultrasound and Primary Care Diagnostic, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOGIQ e?

The FDA product code for LOGIQ e is IYN.

Ge Medical Systems Ultrasound and Primary Care Diagnostic,를 신청인으로 등재한 기타 기록

K231989LOGIQ E10s, LOGIQ 포티스

관련 기기 (코드: IYN)

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