Eko Core Attachment

GUDID 00863609000310

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.

EKO DEVICES, INC.

Electronic stethoscope

• Primary Device ID: 00863609000310
• NIH Device Record Key: 14f0252c-57f8-4790-92e4-6d62e2c07083
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eko Core Attachment
• Version Model Number: Model E4
• Company DUNS: 079670921
• Company Name: EKO DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863609000310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151319

FDA Product Code

• DQD: Stethoscope, Electronic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-26

Devices Manufactured by EKO DEVICES, INC.

• 00850010298733 - CORE 500 Digital Stethoscope - Ruby Earpiece: 2025-03-27 CORE 500 Digital Stethoscope - Ruby Earpiece
• 00850010298245 - CORE 500 Digital Stethoscope FIGS Earpiece - Black: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Black
• 00850010298252 - CORE 500 Digital Stethoscope FIGS Earpiece - Grey: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Grey
• 00850010298269 - CORE 500 Digital Stethoscope FIGS Earpiece - Mauve: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Mauve
• 00850010298276 - CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone
• 00850010298306 - CORE 500 Digital Stethoscope FIGS Earpiece - Royal Blue: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Royal Blue
• 00850010298313 - CORE 500 Digital Stethoscope FIGS Earpiece - Moss: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Moss
• 00850010298399 - CORE 500 Digital Stethoscope FIGS Earpiece - Pink Ribbon: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Pink Ribbon