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510(k) Data Aggregation
K Number
K040802Device Name
HEMOSONIC 200HEMODYNAMIC MONITOR
Manufacturer
ARROW INTL., INC.
Date Cleared
2004-04-28
(30 days)
Product Code
DPN
Regulation Number
862.3700Why did this record match?
Product Code :
DPN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemoSonic™ 200 can be used to observe, diagnose, evaluate, and monitor at-risk patients from 15 to 150 kg by providing hemodynamic information for determining therapeutic actions and maintaining cardiovascular stability.
Device Description
The probe jacket contains the acoustic gel into which the ultrasound crystals are placed. It consists of a plug rod, tip cap, hub, body, acoustic gel and tip.
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