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510(k) Data Aggregation
K Number
K014294Device Name
MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414
Manufacturer
MEDICAL DATA ELECTRONICS
Date Cleared
2002-01-25
(28 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DATA ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medical Data Electronics ESCORT II+ 400 Series Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult, pediatric and neonatal patients in the hospital environment.
Device Description
The modified ESCORT II+ 400 Series (ESCORT Prism) monitor is identical to the currently marketed device with the exception of the functionality of the Pulse Oximeter (SpO2) options available. The predicate device, incorporating Nellcor MP204 technology, does not predicate de id signal processing techniques to compensate for patient motion. The modified device, incorporating Nellcor MP405 technology, incorporates features to compensate for patient motion.
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K Number
K012336Device Name
MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
Manufacturer
MEDICAL DATA ELECTRONICS
Date Cleared
2001-10-03
(71 days)
Product Code
DSI
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DATA ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ESCORT Vision Central Station is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring for a variable number of ESCORT II Bedside Monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.
The ST algorithm has been tested for accuracy of the ST segment measurement data. The significance of the ST segment changes must be determined by a physician.
Device Description
The modified ESCORT Vision Central Station is a central station monitor comprised of a standard VGA display, a standard personal computer base and an auxiliary base or receiver hub used to mount the network communications hardware. The modified Stickman telemetry transmitter is an RF physiological signal transmitter comprised of an ECG measurement system packaged with a UHF transmitter.
The modified ESCORT Vision Central Station provides centralized display, storage and recording (or printing) of patient vital sign and waveform data that are being monitored at ESCORT II, 100, 300 or 400 Series Bedside Monitors or UHF telemetry receivers. The modified Stickman telemetry transmitter provides ECG signal monitoring and RF signal transmission.
The modified ESCORT Vision Central Station with Stickman Telemetry Transmitters communicates in the new WMTS band, providing protection against interference.
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K Number
K000660Device Name
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
Manufacturer
MEDICAL DATA ELECTRONICS
Date Cleared
2000-03-28
(29 days)
Product Code
DRO
Regulation Number
870.5550Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DATA ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992413Device Name
ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
Manufacturer
MEDICAL DATA ELECTRONICS
Date Cleared
1999-08-19
(30 days)
Product Code
DRT, DQA, DTE
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DATA ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medical Data Electronics ESCORT 100/300 Series B Patient Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult, pediatric and neonatal patients in the hospital environment.
Device Description
The modified ESCORT® 100/300 Series B (ESCORT II) Patient Monitor Device is identical to the to the currently marketed device with the exception of the functionality of the Pulse Oximeter (SpO2) Options available. The predicate device, incorporating Nellcor technology, requires user action to invoke special signal processing ('C-Lock') in order to better handle limited patient perfusion. The modified device, incorporating Masimo technology, requires no user action and no 'C-Lock' key to select special signal processing to cope with limited patient perfusion.
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K Number
K992411Device Name
ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
Manufacturer
MEDICAL DATA ELECTRONICS
Date Cleared
1999-08-18
(29 days)
Product Code
DRT, DQA, DTE
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DATA ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medical Data Electronics ESCORT II+ 400 Series Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult, pediatric and neonatal patients in the hospital environment.
Device Description
The modified ESCORT II+ 400 Series (ESCORT Prism) monitor is identical to the to the currently marketed device with the exception of the functionality of the Pulse Oximeter (SpO2) Options available. The predicate device, incorporating Nellcor technology, requires user action to invoke special signal processing ('C-Lock') in order to better handle limited patient perfusion. The modified device, incorporating Masimo technology, requires no user action and no 'C-Lock' key to select special signal processing to cope with limited patient perfusion.
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K Number
K982104Device Name
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
Manufacturer
MEDICAL DATA ELECTRONICS
Date Cleared
1998-11-25
(163 days)
Product Code
MLD
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DATA ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ESCORT-LINK® Central Station Monitor is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring for a variable number of ESCORT® II Bedside Monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.
The ST algorithm has been tested for accuracy of the ST segment measurement data. The significance of the ST segment changes must be determined by a physician.
Device Description
The modified ESCORT-LINK® Central Station Monitor Model 20500 is a Central Station Monitor comprised of a standard VGA display, a standard Personal Computer Base and an auxiliary base used to mount the network communications hardware.
The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide centralized display, storage and recording (or printing) of patient vital sign and waveform data that are being monitored at ESCORT® II, 100, 300 or 400 Series Bedside Monitors or UHF Telemetry Receivers.
Data accumulated at ESCORT® II Bedside Monitors is sent via a proprietary Spread Spectrum Local Area Network to the modified ESCORT-LINK® Central Station Model 20500 for display and storage. Data accumulated from any of Medical Data Electronics' analog or digital telemetry transmitters is sent directly to the central station on standard UHF telemetry frequencies. Telemetry transmitter communication may include patient data similar to that described for the ESCORT® II Bedside Monitors. The modified ESCORT-LINK® Central Station Monitor Model 20500 oversees all communications activity, allowing each system component to pass information without interrupting patient monitoring.
The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide alarm detection and reporting for all vital sign parameters available to the central station. This alarm response is in addition to alarms available at the ESCORT® II 100. 300 or 400 Series Bedside Monitors. Also, arrhythmia monitoring, with ST reporting, is available for up to 16 patients at the Central Station to provide the configurable ability to detect and report certain cardiac abnormalities, including ST abnormalities. Parameter alarms, arrhythmia alarms and ST alarms are independently configurable to accommodate the wide range of patients encountered in the hospital environment.
The Central Station provides storage of patient data. Stored patient data includes waveform and vital sign information. Stored waveform and vital sign data can be retrieved for viewing or printing.
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K Number
K970763Device Name
MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR
Manufacturer
MEDICAL DATA ELECTRONICS
Date Cleared
1997-07-14
(133 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DATA ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MTS Option for the ESCORT II Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment.
Device Description
The MTS Option for the ESCORT® II Monitor is a modular patient monitor capable of monitoring two parameters simultaneously, including dual-vector ECG and SpO2. The MTS Module is equipped with an alphanumeric LCD display that is capable of displaying vital signs providing the detail needed to aid clinical decisions.
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K Number
K970011Device Name
ESCORT II CLINICAL THERMOMETRY MODULE (CTM)
Manufacturer
MEDICAL DATA ELECTRONICS
Date Cleared
1997-07-09
(188 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DATA ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The primary use of the CIM, as an intermittent themmeter, is to take a patient's temperature at a single point in time. However, the instrument's Monitor mode also allows continuous monitoring of the patient's temperature. The CIM is a clinical grade thermometer. It is intended for use by healthcare practitioners only; typically in a hospital, clinic or mobile environment. It is not intended for lay or home use.
The Clinical Themometry Module is intended to be used for the intermittent determination of temperature in hypothermic normothermic of ebrildren or adults, In the Normal mode, oral use in compliant patients allowing maintenance of the sublingual picket for the temperature-taking cycle, enables the predictive algorithm to determine an accurate temperature in approximately 4 seconds. Rectal use results in a predictive temperature in approximately 10 seconds.
Device Description
The CTM consists of an elongated metal heat-conductive probe connected to the multiparameter module (MPM) which may be used with the ESCORT® II Patient Monitor through a coiled cable. The probe contains a thermistor which conveys temperature information to the MPM for calculation of patient temperature which may be displayed on the ESCORT® II display panel.
Prior to use, the probe is inserted into a plastic probe cover. The cover offers no significant barrier to heat transfer from the patient to the probe body. The disposable nature of the probe cover prevents microbiological cross-contamination among patients such as might occur with a reusable probe.
Calculation of patient temperature may, in the normal mode, utilize algorithms which enable accurate temperature prediction within 3 to 10 seconds of probe placement.
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K Number
K970012Device Name
ESCORT LINK CENTRAL STATION MONITOR
Manufacturer
MEDICAL DATA ELECTRONICS
Date Cleared
1997-06-26
(175 days)
Product Code
DSI
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DATA ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ESCORT-LINK™ Central Station Monitor is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia monitoring and alarms for a variable number of ESCORT II bedside monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.
Device Description
The ESCORT LINK Central Station Monitor Model 20500 is a Central Station monitor comprised of a standard VGA Display, a standard Personal Computer Base, and an auxiliary base used to mount the Network communications hardware (i.e. Spread Spectrum transponders and UHF telements of the The ESCORT LINK Central Station Monitor Model 20500 can provide the centralized display, storage, and recording (or printing) of patient vital sign and waveform data that is being monitored at ESCORT II 100, 300, or 400 bedside monitors or UHF Telemetry Receivers.
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K Number
K961138Device Name
ESORT II + 400 SERIES MONITOR
Manufacturer
MEDICAL DATA ELECTRONICS
Date Cleared
1996-12-10
(264 days)
Product Code
DRO
Regulation Number
870.5550Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DATA ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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