HEARTEVENT, MODEL AT— 510(k) K072385

Substantially Equivalent

Diagnostic Devices Pty, Ltd.

FDA 510(k) clearance K072385 for HEARTEVENT, MODEL AT, Substantially Equivalent on 2008-01-11. Applicant: Diagnostic Devices Pty, Ltd..

Clearance details

Applicant
Diagnostic Devices Pty, Ltd.
Product code
Code DXH
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Eastgardens, AU
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