| Primary Device ID | 00850010298191 |
| NIH Device Record Key | bd8f96fc-ce9e-4217-9daf-ad19e84beaef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eko CORE 500 and CAC500 Standard bundle |
| Version Model Number | COR501 |
| Catalog Number | COR501 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00850010298191 [Primary] |
| DQD | Stethoscope, Electronic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-18 |
| Device Publish Date | 2023-07-10 |
| 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 | 2023-07-18Eko CORE 500 and CAC500 Standard bundle |
| 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 |