Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Eko Health with 4 510(k) clearances and 2 AI-enabled devices. The most recent is a 510(k) clearance dated Jul 23, 2026: CORE 300 Digital Stethoscope.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 23, 2026 | CORE 300 Digital StethoscopeK261694 · DQD | 510(k) clearances |
| Aug 12, 2025 | Eko Foundation Analysis Software with Transformers (EFAST)K251494 · DQD | 510(k) clearances |
| Aug 12, 2025 | Eko Foundation Analysis Software with Transformers (EFAST)K251494 · Cardiovascular | AI-enabled devices |
| Mar 28, 2024 | Eko Low Ejection Fraction Tool (ELEFT)K233409 · QYE | 510(k) clearances |
| Mar 28, 2024 | CORE 500 Digital StethoscopeK233609 · DQD | 510(k) clearances |
| Mar 28, 2024 | Eko Low Ejection Fraction Tool (ELEFT)K233409 · Cardiovascular | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
