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FDA 510(k)

Aria System

K-Number: K200564 · 2020-04-03

ApplicantInova Labs
Decision Date2020-04-03
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aria System is a medical device manufactured by Inova Labs. It received FDA 510(k) clearance on 2020-04-03 under approval number K200564. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aria System?

Aria System is a medical device that received FDA 510(k) clearance on 2020-04-03. It is manufactured by Inova Labs. The 510(k) number is K200564.

When was Aria System approved by the FDA?

Aria System received FDA 510(k) clearance on 2020-04-03, under approval number K200564.

What company makes Aria System?

Aria System is manufactured by Inova Labs.

What is the FDA product code for Aria System?

The FDA product code for Aria System is JOW.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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