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FDA 510(k)

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION

K-Number: K093288 · 2010-04-08

ApplicantCardionet, Inc.
Decision Date2010-04-08
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION is the device name listed in this FDA 510(k) record. The listed applicant is Cardionet, Inc.. It received FDA 510(k) clearance on 2010-04-08 under 510(k) number K093288. 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 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION?

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION is a medical device that received FDA 510(k) clearance on 2010-04-08. The listed applicant is Cardionet, Inc.. The 510(k) number is K093288.

When did CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION receive FDA 510(k) clearance?

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION received FDA 510(k) clearance on 2010-04-08, under 510(k) number K093288.

Who is the listed applicant for CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION?

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

What is the FDA product code for CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION?

The FDA product code for CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION is QYX.

Related Clinical Trials

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.

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Other records listing Cardionet, Inc. 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.

K072558CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005K063222CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004K053263CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003K052240CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002K012241CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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