FDA 510(k)

BAC

K-Number: K254131 · 2026-05-21

Decision Date2026-05-21

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BAC is the device name listed in this FDA 510(k) record. The listed applicant is DeepHealth, Inc.. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K254131. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAC?

BAC is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is DeepHealth, Inc.. The 510(k) number is K254131.

When did BAC receive FDA 510(k) clearance?

BAC received FDA 510(k) clearance on 2026-05-21, under 510(k) number K254131.

Who is the listed applicant for BAC?

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

What is the FDA product code for BAC?

The FDA product code for BAC is QIH.

Other records listing DeepHealth, Inc. 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

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