FDA 510(k)

Accurett

K-Number: K161615 · 2016-08-23

Decision Date2016-08-23

Product CodeGEH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Accurett is a medical device manufactured by H&O Equipments, Nv/Sa. It received FDA 510(k) clearance on 2016-08-23 under approval number K161615. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accurett?

Accurett is a medical device that received FDA 510(k) clearance on 2016-08-23. It is manufactured by H&O Equipments, Nv/Sa. The 510(k) number is K161615.

When was Accurett approved by the FDA?

Accurett received FDA 510(k) clearance on 2016-08-23, under approval number K161615.

What company makes Accurett?

Accurett is manufactured by H&O Equipments, Nv/Sa.

What is the FDA product code for Accurett?

The FDA product code for Accurett is GEH.

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Official Source

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