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Cardea SOLO

CARDIAC INSIGHT, INC. · Model D300 · UDI-DI 00857553006139

DSHDQK Prescription
10
510(k) clearances
962
Adverse events (6 deaths)
0
Recalls
57
Facilities

Description

Cardea SOLO PC Software - ECG analysis software (D300)

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.