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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

VyBrate VBR System

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Date Cleared

2026-01-07

(103 days)

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Panel

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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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