FDA.report

510(k) K200564

Device
Aria System
Applicant
Inova Labs
510(k) number
K200564
Product code
JOW  
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-03
Date received
2020-03-04
Regulation
870.5800
Classification name
Sleeve, Limb, Compressible
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Reuben Lawson
Address
7581 Convoy Ct. San Diego CA US 92111 92111

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00860003034743Aria Free™Inova Labs, Inc.2021-03-24
00860003034750Aria Free™Inova Labs, Inc.2021-01-15
00860003034736Aria Free™Inova Labs, Inc.2020-10-27
00860003034729Aria Free™Inova Labs, Inc.2020-10-27
00860003034712Aria Free™Inova Labs, Inc.2020-10-27

Legacy Summary

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FDA Review

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