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CORE 500 Digital Stethoscope - Bundle-ROG

Eko Devices, Inc. · Model E8 · UDI-DI 00850010298979

510(k) clearances

Adverse events

Recalls

Facilities

Description

The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician). The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

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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.