Eko CORE 500 Digital Stethoscope Earpiece CAC500

GUDID 00850010298177

Eko Devices, Inc.

Electronic stethoscope

• Primary Device ID: 00850010298177
• NIH Device Record Key: 4623183a-10d4-47d8-92aa-bf56c390f0cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eko CORE 500 Digital Stethoscope Earpiece
• Version Model Number: CAC500
• Catalog Number: CAC500
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850010298177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230111

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: 2023-07-18
• Device Publish Date: 2023-07-10

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
• 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