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FDA 510(k)

LEGACY

K-Number: K252696 · 2025-11-21

ApplicantPhasor Health, LLC
Decision Date2025-11-21
Product CodeHBG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LEGACY is a medical device manufactured by Phasor Health, LLC. It received FDA 510(k) clearance on 2025-11-21 under approval number K252696. The device is classified under product code HBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEGACY?

LEGACY is a medical device that received FDA 510(k) clearance on 2025-11-21. It is manufactured by Phasor Health, LLC. The 510(k) number is K252696.

When was LEGACY approved by the FDA?

LEGACY received FDA 510(k) clearance on 2025-11-21, under approval number K252696.

What company makes LEGACY?

LEGACY is manufactured by Phasor Health, LLC.

What is the FDA product code for LEGACY?

The FDA product code for LEGACY is HBG.

Other Devices by Phasor Health, LLC

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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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