FDA 510(k)

Wrist 3

K-Number: K160185 · 2016-03-01

Decision Date2016-03-01

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Wrist 3 is a medical device manufactured by Aspect Imaging, Ltd.. It received FDA 510(k) clearance on 2016-03-01 under approval number K160185. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wrist 3?

Wrist 3 is a medical device that received FDA 510(k) clearance on 2016-03-01. It is manufactured by Aspect Imaging, Ltd.. The 510(k) number is K160185.

When was Wrist 3 approved by the FDA?

Wrist 3 received FDA 510(k) clearance on 2016-03-01, under approval number K160185.

What company makes Wrist 3?

Wrist 3 is manufactured by Aspect Imaging, Ltd..

What is the FDA product code for Wrist 3?

The FDA product code for Wrist 3 is LNH.

Other Devices by Aspect Imaging, Ltd.

K170978Embrace Neonatal MRI System K254277Embrace Neonatal MRI System

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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.