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FDA 510(k)

RhythmStar System

K-Number: K233584 · 2024-07-08

ApplicantRhythMedix, LLC
Decision Date2024-07-08
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RhythmStar System is a medical device manufactured by RhythMedix, LLC. It received FDA 510(k) clearance on 2024-07-08 under approval number K233584. The device is classified under product code QYX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RhythmStar System?

RhythmStar System is a medical device that received FDA 510(k) clearance on 2024-07-08. It is manufactured by RhythMedix, LLC. The 510(k) number is K233584.

When was RhythmStar System approved by the FDA?

RhythmStar System received FDA 510(k) clearance on 2024-07-08, under approval number K233584.

What company makes RhythmStar System?

RhythmStar System is manufactured by RhythMedix, LLC.

What is the FDA product code for RhythmStar System?

The FDA product code for RhythmStar System is QYX.

Other Devices by RhythMedix, LLC

K250793RhythmStar System (SL)

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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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