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FDA 510(k)

VisioFocus Mini, VisioFocus Smart

K-Number: K160680 · 2017-04-19

ApplicantTecnimed S.R.L.
Decision Date2017-04-19
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VisioFocus Mini, VisioFocus Smart is a medical device manufactured by Tecnimed S.R.L.. It received FDA 510(k) clearance on 2017-04-19 under approval number K160680. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VisioFocus Mini, VisioFocus Smart?

VisioFocus Mini, VisioFocus Smart is a medical device that received FDA 510(k) clearance on 2017-04-19. It is manufactured by Tecnimed S.R.L.. The 510(k) number is K160680.

When was VisioFocus Mini, VisioFocus Smart approved by the FDA?

VisioFocus Mini, VisioFocus Smart received FDA 510(k) clearance on 2017-04-19, under approval number K160680.

What company makes VisioFocus Mini, VisioFocus Smart?

VisioFocus Mini, VisioFocus Smart is manufactured by Tecnimed S.R.L..

What is the FDA product code for VisioFocus Mini, VisioFocus Smart?

The FDA product code for VisioFocus Mini, VisioFocus Smart is FLL.

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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.

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