FDA 510(k)

Arietta 65

K-Number: K202422 · 2020-11-04

Decision Date2020-11-04

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Arietta 65 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 2020-11-04 under 510(k) number K202422. 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 2020-11-04. The listed applicant is Hitachi Healthcare Americas. The 510(k) number is K202422.

When did Arietta 65 receive FDA 510(k) clearance?

Arietta 65 received FDA 510(k) clearance on 2020-11-04, under 510(k) number K202422.

Who is the listed applicant for Arietta 65?

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 Arietta 65?

The FDA product code for Arietta 65 is IYN.

Other records listing Hitachi Healthcare Americas as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.