ARIETTA 50
K-Number: K190248 · 2019-04-02
ApplicantHitachi Healthcare Americas
Decision Date2019-04-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ARIETTA 50 is a medical device manufactured by Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2019-04-02 under approval number K190248. 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 ARIETTA 50?
ARIETTA 50 is a medical device that received FDA 510(k) clearance on 2019-04-02. It is manufactured by Hitachi Healthcare Americas. The 510(k) number is K190248.
When was ARIETTA 50 approved by the FDA?
ARIETTA 50 received FDA 510(k) clearance on 2019-04-02, under approval number K190248.
What company makes ARIETTA 50?
ARIETTA 50 is manufactured by Hitachi Healthcare Americas.
What is the FDA product code for ARIETTA 50?
The FDA product code for ARIETTA 50 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.