MAC 800 Resting ECG Analysis System— 510(k) K142288

Substantially Equivalent

Ge Medical Systems China Co., Ltd.

FDA 510(k) clearance K142288 for MAC 800 Resting ECG Analysis System, Substantially Equivalent on 2014-12-03. Applicant: Ge Medical Systems China Co., Ltd..

Clearance details

Applicant: Ge Medical Systems China Co., Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2014-08-18
Decision date: 2014-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Wuxi, 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.