AI-ECG Platform— 510(k) K180432

Name: FDA 510(k) clearance K180432
Creator: U.S. Food and Drug Administration
Published: 2018-11-19

Substantially Equivalent

Shenzhen Carewell Electronics., Ltd.

FDA 510(k) clearance K180432 for AI-ECG Platform, Substantially Equivalent on 2018-11-19. Applicant: Shenzhen Carewell Electronics., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Carewell Electronics., Ltd.
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2018-02-20
Decision date: 2018-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQK

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K253692 — AVVIGO+ Multi-Modality Guidance System2026-08-21
K262005 — Affera Integrated Mapping System2026-08-21
K253576 — CorVista System® with PCWP Add-On2026-07-26
K262006 — EnSite X EP System2026-07-15
K252978 — ScioCardio ECG Analysis Platform2026-07-09

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.