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FDA 510(k)

HEARTLINK, MODEL II

K-Number: K982803 · 1998-11-13

ApplicantCardiac Telecom Corp.
Decision Date1998-11-13
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTLINK, MODEL II is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Telecom Corp.. It received FDA 510(k) clearance on 1998-11-13 under 510(k) number K982803. 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 HEARTLINK, MODEL II?

HEARTLINK, MODEL II is a medical device that received FDA 510(k) clearance on 1998-11-13. The listed applicant is Cardiac Telecom Corp.. The 510(k) number is K982803.

When did HEARTLINK, MODEL II receive FDA 510(k) clearance?

HEARTLINK, MODEL II received FDA 510(k) clearance on 1998-11-13, under 510(k) number K982803.

Who is the listed applicant for HEARTLINK, MODEL II?

The FDA 510(k) record lists Cardiac Telecom Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEARTLINK, MODEL II?

The FDA product code for HEARTLINK, MODEL II is QYX.

Related Clinical Trials

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Other records listing Cardiac Telecom Corp. 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.

K934913HEARTRAC ECG MONITORING SYSTEM

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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