CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue CAC500_FCB

GUDID 00810209880002

The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users 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 or by lay users). A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

Eko Devices, Inc.

Electronic acoustic stethoscope

• Primary Device ID: 00810209880002
• NIH Device Record Key: 2f02d6e8-d231-47e4-9b48-a5002fca17a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue
• Version Model Number: E8
• Catalog Number: CAC500_FCB
• Company DUNS: 079670921
• Company Name: Eko Devices, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810209880002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233609

FDA Product Code

• DQD: Stethoscope, Electronic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-06
• Device Publish Date: 2026-01-29

Devices Manufactured by Eko Devices, Inc.

• 00810209880002 - CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue: 2026-02-06The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users 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 or by lay users). A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.
• 00810209880002 - CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue: 2026-02-06 The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and tra
• 00810209880040 - EFAST (Eko Foundation Analysis Software with Transformers): 2026-02-06 The Eko Foundation Analysis Software with Transformers (EFAST) is intended to support healthcare professionals in the evaluation
• 00850010298726 - CORE 500 Digital Stethoscope - Electric Pink Chestpiece: 2025-08-20 CORE 500 Digital Stethoscope - Electric Pink Chestpiece
• 00850010298757 - CORE 500 Digital Stethoscope - Electric Pink Earpiece: 2025-08-20 CORE 500 Digital Stethoscope - Electric Pink Earpiece
• 00850010298788 - CORE 500 Digital Stethoscope - Bundle-SLV: 2025-08-20 CORE 500 Digital Stethoscope - Bundle-SLV
• 00850010298795 - CORE 500 Digital Stethoscope - Bundle-BLK: 2025-08-20 CORE 500 Digital Stethoscope - Bundle-BLK
• 00850010298801 - CORE 500 Digital Stethoscope - Bundle-CHP: 2025-08-20 CORE 500 Digital Stethoscope - Bundle-CHP
• 00850010298818 - CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club Pink: 2025-08-20 CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club Pink