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510(k) Data Aggregation
K Number
K011387Device Name
NEUROTHERM, MODEL JK4Manufacturer
Date Cleared
2001-09-06
(122 days)
Product Code
Regulation Number
882.4725Type
TraditionalPanel
Neurology (NE)Reference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
EUROLINK LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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