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FDA 510(k)

GREEN

K-Number: K252060 · 2025-10-31

Decision Date2025-10-31
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GREEN is a medical device manufactured by Phasor Health, LLC. It received FDA 510(k) clearance on 2025-10-31 under approval 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. It is manufactured by Phasor Health, LLC. The 510(k) number is K252060.

When was GREEN approved by the FDA?

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

What company makes GREEN?

GREEN is manufactured by Phasor Health, LLC.

What is the FDA product code for GREEN?

The FDA product code for GREEN is HBE.

Other Devices by Phasor Health, LLC

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.