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510(k) Data Aggregation
K Number
K010214Device Name
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210Manufacturer
Date Cleared
2001-02-22
(30 days)
Product Code
Regulation Number
870.5310Type
SpecialPanel
CardiovascularReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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