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FDA 510(k)

HEARTRAC ECG MONITORING SYSTEM

K-Number: K934913 · 1995-06-05

ApplicantCardiac Telecom Corp.
Decision Date1995-06-05
Product CodeQYW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTRAC ECG MONITORING SYSTEM 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 1995-06-05 under 510(k) number K934913. The device is classified under product code QYW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTRAC ECG MONITORING SYSTEM?

HEARTRAC ECG MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-05. The listed applicant is Cardiac Telecom Corp.. The 510(k) number is K934913.

When did HEARTRAC ECG MONITORING SYSTEM receive FDA 510(k) clearance?

HEARTRAC ECG MONITORING SYSTEM received FDA 510(k) clearance on 1995-06-05, under 510(k) number K934913.

Who is the listed applicant for HEARTRAC ECG MONITORING SYSTEM?

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 HEARTRAC ECG MONITORING SYSTEM?

The FDA product code for HEARTRAC ECG MONITORING SYSTEM is QYW.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K982803HEARTLINK, MODEL II

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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