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FDA 510(k)

CARDIOTRAK

K-Number: K802089 · 1980-09-26

ApplicantCardiac Pacemakers, Inc.
Decision Date1980-09-26
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTRAK is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pacemakers, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802089. 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 CARDIOTRAK?

CARDIOTRAK is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K802089.

When did CARDIOTRAK receive FDA 510(k) clearance?

CARDIOTRAK received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802089.

Who is the listed applicant for CARDIOTRAK?

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

What is the FDA product code for CARDIOTRAK?

The FDA product code for CARDIOTRAK is DXH. This falls under the Hematology category.

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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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