Search Results
Found 9 results
510(k) Data Aggregation
K Number
K101602Device Name
VITAL SIGNS MONITOR
Manufacturer
CRITICARE SYSTEMS, INC.
Date Cleared
2010-09-01
(85 days)
Product Code
MLD, MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
CRITICARE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
The monitored parameters are:
1. ECG
2. Noninvasive Blood Pressure (NIBP)
3. Invasive Blood Pressure (IBP)
4. Temperature
5. Respiratory Gases
6. Anesthetic Agent Gases
7. Respiratory Rate
8. Pulse Oximetry (SpO2)
9. Arrhythmia and ST Analysis of the ECG waveforms
Device Description
The 9100 monitor measures and displays real time physiological data of the patient, including a graphical plethysmogram and numerical data. The 9100 is a modular system and can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP, Temperature, Respiratory Gases, Anesthetic Agent Gases and SpO2. Arrhythmia and ST Segment analysis of the ECG waveforms is also offered. For all these vital parameters, the 9100 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
Ask a Question
K Number
K091050Device Name
506CN PATIENT MONITOR
Manufacturer
CRITICARE SYSTEMS, INC.
Date Cleared
2009-05-27
(44 days)
Product Code
DRT, DQA
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
CRITICARE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 506CN monitor measures and displays real time physiological data of the patient, including a graphical plethysmogram and numerical data. The 506CN can be used to monitor one or more of the following parameters: Noninvasive BP (NIBP) and SpO2. For all these vital parameters, the 506CN will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
Ask a Question
K Number
K042569Device Name
8600 VITAL SIGNS MONITOR
Manufacturer
CRITICARE SYSTEMS, INC.
Date Cleared
2004-09-29
(8 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
CRITICARE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 8600 monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 8600 can be configured to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP (IBP), SpOz, Temperature, Respiration, CO2, Nominvasive BP (NIDF), Invasive BP Agenta, For all the samini, CO2, N2O, O2 and Halogenated Anesthetic Agents. For all these vital parameters, the 8600 will be capable of limit alams and alerts, printing of strip chart recordings and storing trends for retrospective review.
Ask a Question
K Number
K030613Device Name
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
Manufacturer
CRITICARE SYSTEMS, INC.
Date Cleared
2003-04-17
(50 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
CRITICARE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 alarns and patient data analysis will be available to the care provider from the monitor.
Device Description
The 8100 monitor interprets and displays real time physiological data of the patient including waveforms and numerical data. The 8100 can be custom configured to monitor ECG, Noninvasive BP (NIBP), Invasive BP (IBP), S.O2, Temperature, Respiration, CO2, N.O. O2 and Halogenated Anesthetic Agents. Arrhythmia Detection and ST Analysis software from Brentwood Medical has been incorporated into the 8100 system and uses the extant ECG hardware inputs and microprocessor to enable these capabilities. All user interface elements are provided by the existing 8100 monitor. For each patient vital parameter, the 8100 will be capable of providing limit alarms and alerts, printing of strip chart recordings and storing data trends for retrospective review.
Ask a Question
K Number
K022435Device Name
507EL VITAL SIGNS MONITOR
Manufacturer
CRITICARE SYSTEMS, INC.
Date Cleared
2002-08-14
(20 days)
Product Code
DRT
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
CRITICARE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 507EL monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 507EL can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), SpO3, Temperature, and Respiration. For all these vital parameters, the 507EL will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
Ask a Question
K Number
K012059Device Name
8100/8500 VITAL SIGNS MONITOR
Manufacturer
CRITICARE SYSTEMS, INC.
Date Cleared
2001-08-01
(30 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
CRITICARE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 8100 / 8500 monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 8100 / 8500 can be configured to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP (IBP), SpO2, Temperature, Respiration, CO2, N2O, O2 and Halogenated Anesthetic Agents. For all these vital parameters, the 8100 / 8500 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
Ask a Question
K Number
K001020Device Name
8100 VITAL SIGNS MONITOR
Manufacturer
CRITICARE SYSTEMS, INC.
Date Cleared
2000-04-28
(29 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
CRITICARE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K000276Device Name
MPT 24 AND VITAL VIEW 24
Manufacturer
CRITICARE SYSTEMS, INC.
Date Cleared
2000-03-01
(30 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
CRITICARE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K961223Device Name
MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS
Manufacturer
CRITICARE SYSTEMS, INC.
Date Cleared
1996-12-10
(256 days)
Product Code
LOS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CRITICARE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1