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510(k) Data Aggregation
K Number
K001743Device Name
ULTIMA SMARTBELT, MODEL 0560Manufacturer
Date Cleared
2000-08-25
(78 days)
Product Code
Regulation Number
868.2375Type
SpecialPanel
AnesthesiologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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