FDA 510(k)

EnFocus 2300, EnFocus 4400

K-Number: K162783 · 2016-12-09

Decision Date2016-12-09

Product CodeOBO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

EnFocus 2300, EnFocus 4400 is a medical device manufactured by Bioptigen, Inc.. It received FDA 510(k) clearance on 2016-12-09 under approval number K162783. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EnFocus 2300, EnFocus 4400?

EnFocus 2300, EnFocus 4400 is a medical device that received FDA 510(k) clearance on 2016-12-09. It is manufactured by Bioptigen, Inc.. The 510(k) number is K162783.

When was EnFocus 2300, EnFocus 4400 approved by the FDA?

EnFocus 2300, EnFocus 4400 received FDA 510(k) clearance on 2016-12-09, under approval number K162783.

What company makes EnFocus 2300, EnFocus 4400?

EnFocus 2300, EnFocus 4400 is manufactured by Bioptigen, Inc..

What is the FDA product code for EnFocus 2300, EnFocus 4400?

The FDA product code for EnFocus 2300, EnFocus 4400 is OBO.

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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.