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FDA 510(k)

THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR

K-Number: K103706 · 2011-08-24

ApplicantApplied Cardiac Systems, Inc.
Decision Date2011-08-24
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Applied Cardiac Systems, Inc.. It received FDA 510(k) clearance on 2011-08-24 under 510(k) number K103706. 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 THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR?

THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR is a medical device that received FDA 510(k) clearance on 2011-08-24. The listed applicant is Applied Cardiac Systems, Inc.. The 510(k) number is K103706.

When did THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR receive FDA 510(k) clearance?

THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR received FDA 510(k) clearance on 2011-08-24, under 510(k) number K103706.

Who is the listed applicant for THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR?

The FDA 510(k) record lists Applied Cardiac Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR?

The FDA product code for THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR is QYX.

Related Clinical Trials

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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.K233584RhythmStar SystemRhythMedix, LLCK162956NOWCARDIO SYSTEMContex International Technologies (Canada), 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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