DUO

GUDID 00863609000327

EKO DEVICES, INC.

Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope

• Primary Device ID: 00863609000327
• NIH Device Record Key: 970b4038-8e07-4c14-8ede-21ac9fec8def
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUO
• Version Model Number: E5
• 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: false
• 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	00863609000327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170874

FDA Product Code

• DPS: Electrocardiograph

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: 2018-08-16
• Device Publish Date: 2018-07-16

Devices Manufactured by EKO DEVICES, INC.

• 00850010298160 - Eko CORE 500 Digital Stethoscope Chestpiece: 2023-07-18 Eko CORE 500 Digital Stethoscope Chestpiece
• 00850010298177 - Eko CORE 500 Digital Stethoscope Earpiece: 2023-07-18
• 00850010298191 - Eko CORE 500 and CAC500 Standard bundle: 2023-07-18 Eko CORE 500 and CAC500 Standard bundle
• 00850010298207 - Eko CORE 500 and CAC500 Founder's Edition bundle: 2023-07-18
• 00850010298214 - Eko CORE 500 Founder's Edition Chestpiece: 2023-07-18 Eko CORE 500 Founder's Edition Chestpiece
• 00850010298061 - Eko Mobile App Android International: 2021-04-20 Eko mobile app for android international platforms for use with Eko medical devices.
• 00850010298030 - Eko Analysis Software: 2020-09-16 The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’
• 00850010298009 - Eko Core Digital Attachment: 2020-05-08 The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tub