FDA 510(k)

Accuro

K-Number: K171594 · 2017-10-20

Decision Date2017-10-20

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Accuro is a medical device manufactured by Rivanna Medical, LLC. It received FDA 510(k) clearance on 2017-10-20 under approval number K171594. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accuro?

Accuro is a medical device that received FDA 510(k) clearance on 2017-10-20. It is manufactured by Rivanna Medical, LLC. The 510(k) number is K171594.

When was Accuro approved by the FDA?

Accuro received FDA 510(k) clearance on 2017-10-20, under approval number K171594.

What company makes Accuro?

Accuro is manufactured by Rivanna Medical, LLC.

What is the FDA product code for Accuro?

The FDA product code for Accuro is IYO.

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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.