MAC 2000 ECG ANALYSIS SYSTEM— 510(k) K133622

Substantially Equivalent

Wipro GE Healthcare

FDA 510(k) clearance K133622 for MAC 2000 ECG ANALYSIS SYSTEM, Substantially Equivalent on 2014-01-23. Applicant: Wipro GE Healthcare.

Clearance details

Applicant: Wipro GE Healthcare
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2013-11-22
Decision date: 2014-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, 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.