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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 the device name listed in this FDA 510(k) record. The listed applicant is Tecnimed S.R.L.. It received FDA 510(k) clearance on 2017-04-19 under 510(k) 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. The listed applicant is Tecnimed S.R.L.. The 510(k) number is K160680.

When did VisioFocus Mini, VisioFocus Smart receive FDA 510(k) clearance?

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

Who is the listed applicant for VisioFocus Mini, VisioFocus Smart?

The FDA 510(k) record lists Tecnimed S.R.L. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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