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510(k) Data Aggregation
K Number
K011355Device Name
BIOLIGHT PCDManufacturer
Date Cleared
2002-01-17
(259 days)
Product Code
Regulation Number
890.5500Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
BIOLIGHT INTERNATIONAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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