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FDA 510(k)

AeroDVx Arm System

K-Number: K222823 · 2023-09-07

ApplicantSun Scientific, Inc.
Decision Date2023-09-07
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AeroDVx Arm System is a medical device manufactured by Sun Scientific, Inc.. It received FDA 510(k) clearance on 2023-09-07 under approval number K222823. 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 Arm System?

AeroDVx Arm System is a medical device that received FDA 510(k) clearance on 2023-09-07. It is manufactured by Sun Scientific, Inc.. The 510(k) number is K222823.

When was AeroDVx Arm System approved by the FDA?

AeroDVx Arm System received FDA 510(k) clearance on 2023-09-07, under approval number K222823.

What company makes AeroDVx Arm System?

AeroDVx Arm System is manufactured by Sun Scientific, Inc..

What is the FDA product code for AeroDVx Arm System?

The FDA product code for AeroDVx Arm System is JOW.

Other Devices by Sun Scientific, Inc.

K183349AeroDVx 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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