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510(k) Data Aggregation
K Number
K010292Device Name
DRX 2000Manufacturer
Date Cleared
2001-05-01
(90 days)
Product Code
Regulation Number
890.5900Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Why did this record match?
Device Name :
DRX 2000
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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