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510(k) Data Aggregation
K Number
K010462Manufacturer
Date Cleared
2001-04-11
(54 days)
Product Code
Regulation Number
880.2910Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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