FDA 510(k)

아로카 아리에타 850

K-번호: K183456 · 2019-01-28

결정일2019-01-28

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

Aloka Arietta 850 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K183456. 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 Aloka Arietta 850?

Aloka Arietta 850 is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Hitachi Healthcare Americas. The 510(k) number is K183456.

When did Aloka Arietta 850 receive FDA 510(k) clearance?

Aloka Arietta 850 received FDA 510(k) clearance on 2019-01-28, under 510(k) number K183456.

Who is the listed applicant for Aloka Arietta 850?

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

What is the FDA product code for Aloka Arietta 850?

The FDA product code for Aloka Arietta 850 is IYN.

Hitachi Healthcare Americas를 신청인으로 등재한 기타 기록

K211406OASIS MRI System K202422Arietta 65 K202030OASIS MRI System K200498SCENARIA View K192851OASIS MRI System K190841SCENARIA View

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