PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801— 510(k) K060766

Substantially Equivalent

Omron Healthcare, Inc.

FDA 510(k) clearance K060766 for PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801, Substantially Equivalent on 2006-06-09. Applicant: Omron Healthcare, Inc..

Clearance details

Applicant: Omron Healthcare, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2006-03-22
Decision date: 2006-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, 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.