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FDA 510(k)

HEARTCARD CARDIAC EVENT MONITOR

K-Number: K944362 · 1995-09-07

ApplicantInstromedix, Inc.
Decision Date1995-09-07
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTCARD CARDIAC EVENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1995-09-07 under 510(k) number K944362. 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 HEARTCARD CARDIAC EVENT MONITOR?

HEARTCARD CARDIAC EVENT MONITOR is a medical device that received FDA 510(k) clearance on 1995-09-07. The listed applicant is Instromedix, Inc.. The 510(k) number is K944362.

When did HEARTCARD CARDIAC EVENT MONITOR receive FDA 510(k) clearance?

HEARTCARD CARDIAC EVENT MONITOR received FDA 510(k) clearance on 1995-09-07, under 510(k) number K944362.

Who is the listed applicant for HEARTCARD CARDIAC EVENT MONITOR?

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

What is the FDA product code for HEARTCARD CARDIAC EVENT MONITOR?

The FDA product code for HEARTCARD CARDIAC EVENT MONITOR 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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