K Number
DEN230051Device Name
MyoceneManufacturer
Date Cleared
2025-01-17
(540 days)
Product Code
Regulation Number
882.1871Type
DirectPanel
Physical MedicineReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A