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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 a medical device manufactured by BunkerHill Health. It received FDA 510(k) clearance on 2025-09-19 under approval 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. It is manufactured by BunkerHill Health. The 510(k) number is K250649.

When was Bunkerhill ECG-EF approved by the FDA?

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

What company makes Bunkerhill ECG-EF?

Bunkerhill ECG-EF is manufactured by BunkerHill Health.

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

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

Other Devices by BunkerHill Health

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Related Devices (Code: QYE)

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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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