CMI MAGNETOCARDIOGRAPH— 510(k) K033488

Substantially Equivalent

Cmi Cardiomag Imaging, Inc.

FDA 510(k) clearance K033488 for CMI MAGNETOCARDIOGRAPH, Substantially Equivalent on 2004-07-07. Applicant: Cmi Cardiomag Imaging, Inc..

Clearance details

Applicant: Cmi Cardiomag Imaging, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2003-11-04
Decision date: 2004-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schenectady, NY, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.