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510(k) Data Aggregation
K Number
K010548Date Cleared
2001-03-12
(14 days)
Product Code
Regulation Number
882.4560Type
SpecialPanel
Neurology (NE)Reference & Predicate Devices
N/A
Why did this record match?
Device Name :
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K001431Manufacturer
Date Cleared
2000-05-17
(9 days)
Product Code
Regulation Number
882.4560Type
SpecialPanel
Neurology (NE)Reference & Predicate Devices
N/A
Why did this record match?
Device Name :
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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