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510(k) Data Aggregation
K Number
K001081Device Name
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810Manufacturer
Date Cleared
2000-06-30
(87 days)
Product Code
Regulation Number
870.2770Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
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Device Name :
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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