FDA 510(k)

ALOKA ARIETTA 850

K-Number: K171708 · 2017-10-31

ApplicantHitachi Healthcare Americas Corporation

Decision Date2017-10-31

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ALOKA ARIETTA 850 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas Corporation. It received FDA 510(k) clearance on 2017-10-31 under 510(k) number K171708. 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 2017-10-31. The listed applicant is Hitachi Healthcare Americas Corporation. The 510(k) number is K171708.

When did ALOKA ARIETTA 850 receive FDA 510(k) clearance?

ALOKA ARIETTA 850 received FDA 510(k) clearance on 2017-10-31, under 510(k) number K171708.

Who is the listed applicant for ALOKA ARIETTA 850?

The FDA 510(k) record lists Hitachi Healthcare Americas Corporation 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.

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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.