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FDA 510(k)

RhythmStar System (SL)

K-Number: K250793 · 2026-04-21

ApplicantRhythMedix, LLC
Decision Date2026-04-21
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RhythmStar System (SL) is a medical device manufactured by RhythMedix, LLC. It received FDA 510(k) clearance on 2026-04-21 under approval number K250793. 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 (SL)?

RhythmStar System (SL) is a medical device that received FDA 510(k) clearance on 2026-04-21. It is manufactured by RhythMedix, LLC. The 510(k) number is K250793.

When was RhythmStar System (SL) approved by the FDA?

RhythmStar System (SL) received FDA 510(k) clearance on 2026-04-21, under approval number K250793.

What company makes RhythmStar System (SL)?

RhythmStar System (SL) is manufactured by RhythMedix, LLC.

What is the FDA product code for RhythmStar System (SL)?

The FDA product code for RhythmStar System (SL) is QYX.

Other Devices by RhythMedix, LLC

K233584RhythmStar 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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