LEGACY— 510(k) K252696

Substantially Equivalent

Phasor Health, LLC

FDA 510(k) clearance K252696 for LEGACY, Substantially Equivalent on 2025-11-21. Applicant: Phasor Health, LLC. Device class: 2.

Clearance details

Applicant: Phasor Health, LLC
Product code: Code HBG
Device class: Class 2
Regulation: 21 CFR 882.4300
Advisory panel: Neurology
Date received: 2025-08-27
Decision date: 2025-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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