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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 the device name listed in this FDA 510(k) record. The listed applicant is RhythMedix, LLC. It received FDA 510(k) clearance on 2024-07-08 under 510(k) 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. The listed applicant is RhythMedix, LLC. The 510(k) number is K233584.

When did RhythmStar System receive FDA 510(k) clearance?

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

Who is the listed applicant for RhythmStar System?

The FDA 510(k) record lists RhythMedix, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RhythmStar System?

The FDA product code for RhythmStar System is QYX.

Other records listing RhythMedix, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250793RhythmStar System (SL)

Related Devices (Code: QYX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250793RhythmStar System (SL)RhythMedix, LLCK241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.K240653SmartCardia 7L Platform (MCT)Smartcardia SAK240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.K162956NOWCARDIO SYSTEMContex International Technologies (Canada), Inc.K170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc.

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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