FDA 510(k)

LOGIQ E10

K-번호: K200158 · 2020-04-17

신청자GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

결정일2020-04-17

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

LOGIQ E10 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2020-04-17 under 510(k) number K200158. 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 E10?

LOGIQ E10 is a medical device that received FDA 510(k) clearance on 2020-04-17. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K200158.

When did LOGIQ E10 receive FDA 510(k) clearance?

LOGIQ E10 received FDA 510(k) clearance on 2020-04-17, under 510(k) number K200158.

Who is the listed applicant for LOGIQ E10?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOGIQ E10?

The FDA product code for LOGIQ E10 is IYN.

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC를 신청인으로 등재한 기타 기록

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