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510(k) Data Aggregation
K Number
K011107Device Name
MODIFICATION TO SOLOManufacturer
Date Cleared
2001-05-14
(28 days)
Product Code
Regulation Number
890.3800Type
SpecialPanel
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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