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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 the device name listed in this FDA 510(k) record. The listed applicant is Inova Labs. It received FDA 510(k) clearance on 2020-04-03 under 510(k) 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. The listed applicant is Inova Labs. The 510(k) number is K200564.

When did Aria System receive FDA 510(k) clearance?

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

Who is the listed applicant for Aria System?

The FDA 510(k) record lists Inova Labs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aria System?

The FDA product code for Aria System is JOW.

Related Devices (Code: JOW)

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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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