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FDA 510(k)

Bunkerhill ECG-EF

K-Number: K250649 · 2025-09-19

ApplicantBunkerHill Health
Decision Date2025-09-19
Product CodeQYE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bunkerhill ECG-EF is the device name listed in this FDA 510(k) record. The listed applicant is BunkerHill Health. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K250649. The device is classified under product code QYE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bunkerhill ECG-EF?

Bunkerhill ECG-EF is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is BunkerHill Health. The 510(k) number is K250649.

When did Bunkerhill ECG-EF receive FDA 510(k) clearance?

Bunkerhill ECG-EF received FDA 510(k) clearance on 2025-09-19, under 510(k) number K250649.

Who is the listed applicant for Bunkerhill ECG-EF?

The FDA 510(k) record lists BunkerHill Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bunkerhill ECG-EF?

The FDA product code for Bunkerhill ECG-EF is QYE.

Other records listing BunkerHill Health as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: QYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc.K250119Tempus ECG-Low EFTempus AI, Inc.K233409Eko Low Ejection Fraction Tool (ELEFT)Eko Health, Inc.K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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