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FDA 510(k)

CADence System

K-Number: K170928 · 2017-08-03

ApplicantAum Cardiovascular, Inc.
Decision Date2017-08-03
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CADence System is a medical device manufactured by Aum Cardiovascular, Inc.. It received FDA 510(k) clearance on 2017-08-03 under approval number K170928. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADence System?

CADence System is a medical device that received FDA 510(k) clearance on 2017-08-03. It is manufactured by Aum Cardiovascular, Inc.. The 510(k) number is K170928.

When was CADence System approved by the FDA?

CADence System received FDA 510(k) clearance on 2017-08-03, under approval number K170928.

What company makes CADence System?

CADence System is manufactured by Aum Cardiovascular, Inc..

What is the FDA product code for CADence System?

The FDA product code for CADence System is DQD.

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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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