K203786

Substantially Equivalent

MAC 7 - Resting ECG Analysis System

Applicant: Ge Medical Systems Information Technologies, Inc.
Product code: DPS
Advisory panel: Cardiovascular
Date received: 2020-12-28
Decision date: 2021-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wauwatosa, WI, US

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.