Aloka Arietta 850
K-Number: K183456 · 2019-01-28
ApplicantHitachi Healthcare Americas
Decision Date2019-01-28
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Aloka Arietta 850 is a medical device manufactured by Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2019-01-28 under approval number K183456. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aloka Arietta 850?
Aloka Arietta 850 is a medical device that received FDA 510(k) clearance on 2019-01-28. It is manufactured by Hitachi Healthcare Americas. The 510(k) number is K183456.
When was Aloka Arietta 850 approved by the FDA?
Aloka Arietta 850 received FDA 510(k) clearance on 2019-01-28, under approval number K183456.
What company makes Aloka Arietta 850?
Aloka Arietta 850 is manufactured by Hitachi Healthcare Americas.
What is the FDA product code for Aloka Arietta 850?
The FDA product code for Aloka Arietta 850 is IYN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.