Bunkerhill ECG-EF— 510(k) K250649

Substantially Equivalent

BunkerHill Health

FDA 510(k) clearance K250649 for Bunkerhill ECG-EF, Substantially Equivalent on 2025-09-19. Applicant: BunkerHill Health. Device class: 2.

Clearance details

Applicant: BunkerHill Health
Product code: Code QYE
Device class: Class 2
Regulation: 21 CFR 870.2380
Advisory panel: Cardiovascular
Date received: 2025-03-04
Decision date: 2025-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QYE

K250652 — ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)2025-07-28
K250119 — Tempus ECG-Low EF2025-07-15
K233409 — Eko Low Ejection Fraction Tool (ELEFT)2024-03-28
K232699 — Low Ejection Fraction AI-ECG Algorithm2023-09-28

More clearances from BunkerHill Health

K260166 — Bunkerhill Contrast CAC2026-03-06
K260167 — Bunkerhill Contrast AVC2026-03-06
K250662 — Bunkerhill MAC2025-10-03
K243779 — Bunkerhill Abdominal Aortic Quantification (AAQ)2025-07-01
K242295 — BunkerHill BMD2025-04-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.