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

Name: FDA 510(k) clearance K142288
Creator: U.S. Food and Drug Administration
Published: 2014-12-03

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.. Device class: 2.

Clearance details

Applicant: Ge Medical Systems China Co., Ltd.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2014-08-18
Decision date: 2014-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Wuxi, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPS

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K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)2026-07-02
K251670 — MAC 7 Resting ECG Analysis System2026-01-26
K252361 — AccurECG Analysis System (v2.0)2025-12-22
K252474 — Withings BeamO (SCT02)2025-11-10
K250569 — Cardiologs Holter Platform2025-08-06

More clearances from Ge Medical Systems China Co., Ltd.

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K151063 — Monitor B402015-12-15
K133576 — MONITOR B402014-02-21
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K122253 — PROCARE MONITOR B202013-03-22

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.