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510(k) Data Aggregation
K Number
K000619Device Name
SCANDINAVIAN IVF SCIENCES AB, G2.2Manufacturer
Date Cleared
2000-06-27
(131 days)
Product Code
Regulation Number
884.6180Type
TraditionalReference & Predicate Devices
N/A
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Device Name :
SCANDINAVIAN IVF SCIENCES AB, G2.2
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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