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FDA 510(k)

AeroDVx System

K-Number: K183349 · 2019-07-19

ApplicantSun Scientific, Inc.
Decision Date2019-07-19
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AeroDVx System is a medical device manufactured by Sun Scientific, Inc.. It received FDA 510(k) clearance on 2019-07-19 under approval number K183349. 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 AeroDVx System?

AeroDVx System is a medical device that received FDA 510(k) clearance on 2019-07-19. It is manufactured by Sun Scientific, Inc.. The 510(k) number is K183349.

When was AeroDVx System approved by the FDA?

AeroDVx System received FDA 510(k) clearance on 2019-07-19, under approval number K183349.

What company makes AeroDVx System?

AeroDVx System is manufactured by Sun Scientific, Inc..

What is the FDA product code for AeroDVx System?

The FDA product code for AeroDVx System is JOW.

Other Devices by Sun Scientific, Inc.

K222823AeroDVx Arm System

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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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