| Primary Device ID | 00810209880040 |
| NIH Device Record Key | 5954dc64-1d16-452f-a348-5d335ce5e252 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EFAST (Eko Foundation Analysis Software with Transformers) |
| Version Model Number | 1.x.x |
| Catalog Number | EFAST |
| 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 | false |
| Serial Number | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00810209880040 [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 | 2026-02-06 |
| Device Publish Date | 2026-01-29 |
| 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) | 2026-02-06The Eko Foundation Analysis Software with Transformers (EFAST) is intended to support healthcare professionals in the evaluation of patients’ heart sounds and electrocardiograms (ECGs). The software calculates heart rate, detects the presence of murmurs associated with Structural Heart Disease, and determines murmur timing including the timing of S1, S2 heart sounds. When ECG is available, the software detects the presence of atrial fibrillation and normal sinus rhythm. The software is intended for use by or under the supervision of a healthcare professional and is not to be used as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are designed to support and not replace the healthcare professional’s clinical judgment. The murmur detection is intended for use on both pediatric and adult patients, while the detection of atrial fibrillation is intended for use on adults (> 18 years). |
| 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 |