FDA 510(k)

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K-번호: K190039 · 2019-03-08

결정일2019-03-08

제품 코드IYO

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

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기기 요약

EchoSure Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Sonavex, Inc.. It received FDA 510(k) clearance on 2019-03-08 under 510(k) number K190039. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the EchoSure Diagnostic Ultrasound System?

EchoSure Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-03-08. The listed applicant is Sonavex, Inc.. The 510(k) number is K190039.

When did EchoSure Diagnostic Ultrasound System receive FDA 510(k) clearance?

EchoSure Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-03-08, under 510(k) number K190039.

Who is the listed applicant for EchoSure Diagnostic Ultrasound System?

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

What is the FDA product code for EchoSure Diagnostic Ultrasound System?

The FDA product code for EchoSure Diagnostic Ultrasound System is IYO.

Sonavex, Inc.를 신청인으로 등재한 기타 기록

K243479에코가이드 (버전 1)K180621에코마크, 에코마크 LP

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