ARIETTA 65
K-Number: K181376 · 2018-07-18
Decision Date2018-07-18
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ARIETTA 65 is a medical device manufactured by Hitachi Healthcare Americas Corporation. It received FDA 510(k) clearance on 2018-07-18 under approval number K181376. 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 65?
ARIETTA 65 is a medical device that received FDA 510(k) clearance on 2018-07-18. It is manufactured by Hitachi Healthcare Americas Corporation. The 510(k) number is K181376.
When was ARIETTA 65 approved by the FDA?
ARIETTA 65 received FDA 510(k) clearance on 2018-07-18, under approval number K181376.
What company makes ARIETTA 65?
ARIETTA 65 is manufactured by Hitachi Healthcare Americas Corporation.
What is the FDA product code for ARIETTA 65?
The FDA product code for ARIETTA 65 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.