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FDA 510(k)

Bunkerhill MAC

K-Number: K250662 · 2025-10-03

ApplicantBunkerHill Health
Decision Date2025-10-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bunkerhill MAC is the device name listed in this FDA 510(k) record. The listed applicant is BunkerHill Health. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K250662. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bunkerhill MAC?

Bunkerhill MAC is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is BunkerHill Health. The 510(k) number is K250662.

When did Bunkerhill MAC receive FDA 510(k) clearance?

Bunkerhill MAC received FDA 510(k) clearance on 2025-10-03, under 510(k) number K250662.

Who is the listed applicant for Bunkerhill MAC?

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 MAC?

The FDA product code for Bunkerhill MAC is JAK.

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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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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