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FDA 510(k)

THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM

K-Number: K974679 · 1998-03-23

ApplicantMedcon , Ltd.
Decision Date1998-03-23
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medcon , Ltd.. It received FDA 510(k) clearance on 1998-03-23 under 510(k) number K974679. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM?

THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-23. The listed applicant is Medcon , Ltd.. The 510(k) number is K974679.

When did THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM receive FDA 510(k) clearance?

THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM received FDA 510(k) clearance on 1998-03-23, under 510(k) number K974679.

Who is the listed applicant for THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM?

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

What is the FDA product code for THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM?

The FDA product code for THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM is IZI.

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Official Source

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