AeroDVx System— 510(k) K183349

Substantially Equivalent

Sun Scientific, Inc.

FDA 510(k) clearance K183349 for AeroDVx System, Substantially Equivalent on 2019-07-19. Applicant: Sun Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Sun Scientific, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2018-12-03
Decision date: 2019-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dobbs Ferry, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.