Eko Devices, Inc.

Address:1212 Broadway, Suite 100,Oakland,CA,94612,US

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Device Description : The Eko Core Attachment connects to (and digitizes) the analog stethoscope you a The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds.

Device Class : 2

Duns Number: 079670921

Premarket Exempt : No

Product Code : DQD

Prescription Use : Yes

Device Count : 1

Device Description : The Eko Core Electronic Stethoscope is a complete electronic stethoscope with di The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds.

Device Class : 2

Duns Number: 079670921

Premarket Exempt : No

Product Code : DQD

Prescription Use : Yes

Device Count : 1

Device Description : The Eko Analysis Software is intended to provide support to the physician in the The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart soundsand ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence ofsuspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normalsinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRSduration and EMAT. The software does not distinguish between different kinds of murmurs and does not identifyother arrhythmias.It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the softwareare only significant when used in conjunction with physician over-read and is for use on adults (> 18 years)

Device Class : 2

Duns Number: 079670921

Premarket Exempt : No

Product Code : MWI, DPS, DQD

Prescription Use : Yes

Device Count : 1

Device Description : Eko mobile app for android international platforms for use with Eko medical devices.

Device Class : 1

Duns Number: 079670921

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

Device Description : The Eko Core Electronic Stethoscope is a complete electronic stethoscope with di The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds.

Device Class : 2

Duns Number: 079670921

Premarket Exempt : No

Product Code : DQD

Prescription Use : Yes

Device Count : 1

Device Description : The Eko Core Attachment connects to (and digitizes) the analog stethoscope you a The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds.

Device Class : 2

Duns Number: 079670921

Premarket Exempt : No

Product Code : DQD

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Class : 2

Duns Number: 079670921

Premarket Exempt : No

Product Code : DPS, DQD

Prescription Use : Yes

Device Count : 1

Device Description : iOS mobile device software for use with Eko products.

Device Class : 1

Duns Number: 079670921

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

Device Description : Eko mobile app for Android platforms for use with Eko products.

Device Class : 1

Duns Number: 079670921

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

Device Description : Windows PC Application for use with Eko products.

Device Class : 1

Duns Number: 079670921

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1