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FDA 510(k)

HeartFocus

K-Number: K260780 · 2026-06-03

ApplicantDeski
Decision Date2026-06-03
Product CodeQJU
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HeartFocus is the device name listed in this FDA 510(k) record. The listed applicant is Deski. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K260780. The device is classified under product code QJU. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HeartFocus?

HeartFocus is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Deski. The 510(k) number is K260780.

When did HeartFocus receive FDA 510(k) clearance?

HeartFocus received FDA 510(k) clearance on 2026-06-03, under 510(k) number K260780.

Who is the listed applicant for HeartFocus?

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

What is the FDA product code for HeartFocus?

The FDA product code for HeartFocus is QJU.

Other records listing Deski 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.

Related Devices (Code: QJU)

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.

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.