MAC 800 RESTING ECG ANALYSIS SYSTEM— 510(k) K090212

Substantially Equivalent

Ge Medical Syst. Information Technologies

FDA 510(k) clearance K090212 for MAC 800 RESTING ECG ANALYSIS SYSTEM, Substantially Equivalent on 2009-02-19. Applicant: Ge Medical Syst. Information Technologies.

Clearance details

Applicant: Ge Medical Syst. Information Technologies
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2009-01-28
Decision date: 2009-02-19
Decision: Substantially Equivalent
Clearance type: Special
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.