FDA 510(k)

FUJIFILM Sonosite Vevo MD Imaging System

K-번호: K190476 · 2019-03-15

결정일2019-03-15

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

FUJIFILM Sonosite Vevo MD Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K190476. 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 FUJIFILM Sonosite Vevo MD Imaging System?

FUJIFILM Sonosite Vevo MD Imaging System is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K190476.

When did FUJIFILM Sonosite Vevo MD Imaging System receive FDA 510(k) clearance?

FUJIFILM Sonosite Vevo MD Imaging System received FDA 510(k) clearance on 2019-03-15, under 510(k) number K190476.

Who is the listed applicant for FUJIFILM Sonosite Vevo MD Imaging System?

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

What is the FDA product code for FUJIFILM Sonosite Vevo MD Imaging System?

The FDA product code for FUJIFILM Sonosite Vevo MD Imaging System is IYN.

FUJIFILM Sonosite, Inc.를 신청인으로 등재한 기타 기록

K260595Sonosite iLOOK Ultrasound System K253448Sonosite MT Ultrasound System K251106Sonosite LX and Sonosite PX Ultrasound Systems K251830Sonosite LX Ultrasound System K233597Sonosite LX Ultrasound System K213763Sonosite PX Ultrasound System

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