MAC 7 - Resting ECG Analysis System— 510(k) K203786

Substantially Equivalent

Ge Medical Systems Information Technologies, Inc.

FDA 510(k) clearance K203786 for MAC 7 - Resting ECG Analysis System, Substantially Equivalent on 2021-04-30. Applicant: Ge Medical Systems Information Technologies, Inc..

Clearance details

Applicant: Ge Medical Systems Information Technologies, Inc.
Product code: 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

Download summary PDF View on FDA.gov ↗

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.