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FDA 510(k)

Adaptivo

K-Number: K152994 · 2016-02-03

ApplicantAurora Technology Development, LLC
Decision Date2016-02-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Adaptivo is a medical device manufactured by Aurora Technology Development, LLC. It received FDA 510(k) clearance on 2016-02-03 under approval number K152994. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Adaptivo?

Adaptivo is a medical device that received FDA 510(k) clearance on 2016-02-03. It is manufactured by Aurora Technology Development, LLC. The 510(k) number is K152994.

When was Adaptivo approved by the FDA?

Adaptivo received FDA 510(k) clearance on 2016-02-03, under approval number K152994.

What company makes Adaptivo?

Adaptivo is manufactured by Aurora Technology Development, LLC.

What is the FDA product code for Adaptivo?

The FDA product code for Adaptivo is IYE.

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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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