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FDA 510(k)

BunkerHill BMD

K-Number: K242295 · 2025-04-08

Decision Date2025-04-08
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BunkerHill BMD is a medical device manufactured by BunkerHill Health. It received FDA 510(k) clearance on 2025-04-08 under approval number K242295. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BunkerHill BMD?

BunkerHill BMD is a medical device that received FDA 510(k) clearance on 2025-04-08. It is manufactured by BunkerHill Health. The 510(k) number is K242295.

When was BunkerHill BMD approved by the FDA?

BunkerHill BMD received FDA 510(k) clearance on 2025-04-08, under approval number K242295.

What company makes BunkerHill BMD?

BunkerHill BMD is manufactured by BunkerHill Health.

What is the FDA product code for BunkerHill BMD?

The FDA product code for BunkerHill BMD is KGI.

Other Devices by BunkerHill Health

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Related Devices (Code: KGI)

Official Source

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