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510(k) Data Aggregation
K Number
K010894Device Name
BABY DOPPLEX 3002 (BD3002)Manufacturer
Date Cleared
2001-04-25
(30 days)
Product Code
Regulation Number
884.2740Type
SpecialReference & Predicate Devices
N/A
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Device Name :
BABY DOPPLEX 3002 (BD3002)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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