ELECTROCARDIOGRAPH— 510(k) K120188

Substantially Equivalent

Edan Instruments, Inc.

FDA 510(k) clearance K120188 for ELECTROCARDIOGRAPH, Substantially Equivalent on 2012-03-16. Applicant: Edan Instruments, Inc..

Clearance details

Applicant: Edan Instruments, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2012-01-23
Decision date: 2012-03-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, CN

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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.