Aria System— 510(k) K200564

Substantially Equivalent

Inova Labs

FDA 510(k) clearance K200564 for Aria System, Substantially Equivalent on 2020-04-03. Applicant: Inova Labs. Device class: 2.

Clearance details

Applicant
Inova Labs
Product code
Code JOW
Device class
Class 2
Regulation
21 CFR 870.5800
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
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