FDA 510(k)

Aingeal Activity System

K-Number: K153275 · 2016-02-26

Decision Date2016-02-26

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Aingeal Activity System is a medical device manufactured by Intelesens, Ltd.. It received FDA 510(k) clearance on 2016-02-26 under approval number K153275. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aingeal Activity System?

Aingeal Activity System is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Intelesens, Ltd.. The 510(k) number is K153275.

When was Aingeal Activity System approved by the FDA?

Aingeal Activity System received FDA 510(k) clearance on 2016-02-26, under approval number K153275.

What company makes Aingeal Activity System?

Aingeal Activity System is manufactured by Intelesens, Ltd..

What is the FDA product code for Aingeal Activity System?

The FDA product code for Aingeal Activity System is MHX.

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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.