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510(k) Data Aggregation
K Number
K051038Device Name
506 PATIENT MONITOR
Manufacturer
CIRITICARE SYSTEMS, INC.
Date Cleared
2005-08-12
(109 days)
Product Code
DRT
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
CIRITICARE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 506 Patient monitor interprets and displays real time physiological data of the patient. The 506 is configured to monitor Noninvasive BP (NIBP), SpO2, and Temperature. For each patient vital parameter, the 506 will be capable of providing limit alarms and alerts, printing of strip chart recordings and storing data trends for retrospective review. The 506 monitor has utilized existing core technologies from the predicate 507EL monitor for patient monitoring of NIBP, SpO2, and Temperature. Temperature measurement is provided by Kendall's Filac FasTemp module which has been integrated into the 506 monitor. This temperature measurement technology allows predictive or continuous temperature measurement on adult or pediatric patients in oral, axillar, or rectal placements. SpO2 can optionally be provided by Nellcor's SpO2 module. This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
Device Description
The 506 monitor measures and displays real time physiological data of the patient, including a pulse bar plethysmogram and numerical data. The 506 can be used to monitor one or more of the following parameters: Noninvasive BP (NIBP), SpO2, and Temperature. For all these vital parameters, the 506 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
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