FDA 510(k)

GREEN

K-Number: K252060 · 2025-10-31

Decision Date2025-10-31

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

GREEN is the device name listed in this FDA 510(k) record. The listed applicant is Phasor Health, LLC. It received FDA 510(k) clearance on 2025-10-31 under 510(k) number K252060. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GREEN?

GREEN is a medical device that received FDA 510(k) clearance on 2025-10-31. The listed applicant is Phasor Health, LLC. The 510(k) number is K252060.

When did GREEN receive FDA 510(k) clearance?

GREEN received FDA 510(k) clearance on 2025-10-31, under 510(k) number K252060.

Who is the listed applicant for GREEN?

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

What is the FDA product code for GREEN?

The FDA product code for GREEN is HBE.

Other records listing Phasor Health, LLC 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.

K252696LEGACY K252514EVAC-MRI K250505EZ-FIDUCIALS K243205EVAC

Related Devices (Code: HBE)

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.