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FDA 510(k)

HEARTEVENT, MODEL AT

K-Number: K072385 · 2008-01-11

ApplicantDiagnostic Devices Pty, Ltd.
Decision Date2008-01-11
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTEVENT, MODEL AT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Devices Pty, Ltd.. It received FDA 510(k) clearance on 2008-01-11 under 510(k) number K072385. 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 HEARTEVENT, MODEL AT?

HEARTEVENT, MODEL AT is a medical device that received FDA 510(k) clearance on 2008-01-11. The listed applicant is Diagnostic Devices Pty, Ltd.. The 510(k) number is K072385.

When did HEARTEVENT, MODEL AT receive FDA 510(k) clearance?

HEARTEVENT, MODEL AT received FDA 510(k) clearance on 2008-01-11, under 510(k) number K072385.

Who is the listed applicant for HEARTEVENT, MODEL AT?

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

What is the FDA product code for HEARTEVENT, MODEL AT?

The FDA product code for HEARTEVENT, MODEL AT 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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