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FDA 510(k)

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K 號：K252060 · 2025-10-31

申請人Phasor Health, LLC
決定日期2025-10-31
產品代碼HBE
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

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.

常見問題

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.

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