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FDA 510(k)

TELZUIT CARDIAC MONITORING SYSTEM

K-Number: K031229 · 2003-07-09

ApplicantTelzuit Technologies, Inc.
Decision Date2003-07-09
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELZUIT CARDIAC MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Telzuit Technologies, Inc.. It received FDA 510(k) clearance on 2003-07-09 under 510(k) number K031229. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELZUIT CARDIAC MONITORING SYSTEM?

TELZUIT CARDIAC MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2003-07-09. The listed applicant is Telzuit Technologies, Inc.. The 510(k) number is K031229.

When did TELZUIT CARDIAC MONITORING SYSTEM receive FDA 510(k) clearance?

TELZUIT CARDIAC MONITORING SYSTEM received FDA 510(k) clearance on 2003-07-09, under 510(k) number K031229.

Who is the listed applicant for TELZUIT CARDIAC MONITORING SYSTEM?

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

What is the FDA product code for TELZUIT CARDIAC MONITORING SYSTEM?

The FDA product code for TELZUIT CARDIAC MONITORING SYSTEM is DXH. This falls under the Hematology category.

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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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