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510(k) Data Aggregation
K Number
K103686Device Name
STAR 50 N
Manufacturer
LARSEN & TOUBRO LIMITED
Date Cleared
2011-03-15
(88 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
**LARSEN **& TOUBRO LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Star 50N multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric and neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unpin Vital signs parameters include ECG (3 lead / 5 lead), SpO2, Respiration, Temperature, external optional Capnography (CO₂). It can also display the digital values of HR/PR, SPO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EyCO2, and FiCO2.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Device Description
STAR 50N is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, IBP, Temperature, SpO2 and external CO2 (optional).
STAR 50N is a 6-channel monitor with 10.4" TFT display capable of displaying ECG, Respiration, Spo2, CO2, digital values of HR/PR, SpO2, RR, Non-Invasive Blood pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has 168 Hours tabular and graphical trends. It has special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall facility with last 24 patient alarms details. It has a two-channel thermal array recorder for printing of Tabular trends & waveforms. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It has got optional communication features - USB, Wi/Fi (optional) and Ethernet. This monitor can also be connected to L&T Central Nursing Station (Skyline 55) and an external LCD-TFT display
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K Number
K103763Device Name
STELLAR 300
Manufacturer
LARSEN & TOUBRO LIMITED
Date Cleared
2011-03-11
(78 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
**LARSEN **& TOUBRO LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric and neonate patient's vital signs at the benside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameter includes Plethysmograph. It can also disolay the digital wallus of PR, SpO2, Non-Invasive Blood Pressure (Systolic Diastolic and Mean) and Temperature readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device, which can also be used as a portable device, permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
Device Description
This STELLAR 300 unit is a 3 parameter Patient monitor System (TFT color monitor) with NIBP, Pulse oximetry and Temperature with an inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.
STELLAR 300 have waveform display capability for Plethysmograph. It also displays Meen of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Displays Mean) and Temperatire readings. It has graded and color coded alarms It has 2 hours and 12 hours tabular and graphical trends for SpO2 and Temperature. It has special tabular trend for NIBP to store the last 100 readings. Alarm recall feature offers last 16 alarm conditions.
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K Number
K093017Device Name
STELLAR 300
Manufacturer
LARSEN & TOUBRO LIMITED
Date Cleared
2010-04-29
(212 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
**LARSEN **& TOUBRO LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult or Pediatric patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameter includes Plethysmograph. It can also display the digital values of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device, which can also be used as a portable device, permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
Device Description
This STELLAR 300 unit is a 3 parameter Patient monitor System (TFT color monitor) with NIBP, Pulse oximetry and Temperature with an inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.
STELLAR 300 have waveform display capability for Plethysmograph. It also displays the digital values of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature readings. It has graded and color coded alarms. It has 2 hours and 12 hours tabular and graphical trends for SpO2 and Temperature. It has special module and trend for NIBP to store the last 100 readings. Alarm recall feature offers last 16 alarm conditions.
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K Number
K092153Device Name
SKYLINE 55, MODEL VER 1
Manufacturer
LARSEN & TOUBRO LIMITED
Date Cleared
2009-11-20
(127 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
**LARSEN **& TOUBRO LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Skyline55 Ver 1 is Central Nursing System Software that is loaded in a PC, which in turn is connected to a listed patient monitor via an Ethernet communication (wired or wireless). The system software will enable a user to simultaneously monitor 8/16 beds. The system software will make available to the user, patient information in the form of continuous monitoring along with extended features in which 72-hour trend data can be stored for each patient and displayed in the form of Waveform recall, Graphical and Tabular Trends. Alarm records for 72-hours too are recorded and stored for each patient connected to the system software.
Skyline 55 Ver1 is intended to conduct centralized monitoring for adult, pediatric and neonatal patients' vital sign information from multiple monitors in a hospital, the monitoring parameters include ECG, NIBP, SPO2, RESP, IBP, TEMP, CO2 and Anesthesia agents.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The system software permits patient monitoring with adjustable visible and audible alarm signals. The system software is not intended for home use.
Device Description
Central Nursing Station is a kind of medical information system widely applied in clinical monitoring, whose operation requires specific hardware environment such as a PC loaded with an Operating System and a software application. The loaded PC system is connected with multiple individual bedside monitors through a communication channel (In Skyline55 case wired Ethernet 802.3 and wireless 802.11bg). It can collect the monitoring information of the patient transferred via interface from the bedside monitor. It can also display and export the integrated information from bedside monitors so as to free-up doctors from clinical monitoring work and create centralized monitoring management.
The Skyline55 Ver1 is such Central Nursing Station software which is loaded in a PC of recommended specifications. The system set-up includes a FCC approved highperformance PC hardware system, the application software and Windows operation system (Windows XP). Through applying Larsen & Toubro specified protocol, the Central Monitoring System receives physiological information from cleared bedside monitors manufactured by Larsen & Toubro, includes: Planet 50, Star 50, Galaxy, Planet 55, Star 55 and Galaxy 55.
Skyline 55 Verl can maximally support the simultaneous interfacing of 16 bedside monitors. TCP/IP protocol is applied to ensure reliable transmission of data between the bedside monitors and the Central Nursing Station using Cat5e cable.
Skyline 55 Ver1 offers centralized display of physiological information of many patients who are monitored simultaneously. The software can support one display with display information from up to 16 bedside monitors. If any of the bedside monitors gives off a patient vital sign parameter alarm (also referred as Red Alam), prompt information will be immediately displayed by means of audible and visual alarm for medical personnel attention.
The physiological waveforms displayed on Skyline 55 Ver1 include: ECG, RESP, CO2, SPO2, IBP and Anesthesia agents. The physiological parameters displayed on the central monitoring system include: HR, RR, SPO2, SysDia/Mean NIBP and IBP, TEMP and CO2, Archythmia, ST indications and Anesthesia agents. The software also performs notification directly for Red alarms from the bedside monitor. Moreover database technology is applied to store these from the bedside monitor.
Skyline 55 Ver1 is used to provide a secondary display/announcement for the physiological parameters based on the bedside monitor and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions.
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K Number
K090172Device Name
STAR 55 MODEL 100
Manufacturer
LARSEN & TOUBRO LIMITED
Date Cleared
2009-06-05
(133 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
**LARSEN **& TOUBRO LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STAR 55 Model 100 multi-parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead/ 12 lead), SpO2, Respiration, Temperature, Capnography (CO2) & optional Gas module unit. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean); Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, N2O, O2, EtAA and FiAA readings.
In addition, Star 55 Model 100 has got Arrhythmia and ST detection from 3L/5L/12L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
Device Description
STAR 55 Model 100 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5/12 lead), Arrhythmia & ST analysis, Respiration, NIBP, IBP, Temperature, SpO2, CO2 & Gas monitoring,
STAR 55 Model 100 is a 8-channel monitor with 12.1" TFT display capable of displaying ECG, Respiration, SpO2, CO2, digital values of HR/PR. SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blond Pressure (Systolic. Diastolic and Mean), Temperature, EtCO2, FiCO2, NoO. O2, EtAA and FiAA readings. It has selective 2448172 Hours tabular and graphical trends. It han special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall facilius with last 24 patient alarms details. It has a two-channel thermal array recorder for printing of Tabular trends & waveforms. It has got optional communication fratures . USB, RS232, Infrared remote and Ethernet. The device permits patient monitoring with adjustable aların limits as well as visible and audible alarm signals.
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K Number
K090443Device Name
PLANET 55, MODEL 100
Manufacturer
LARSEN & TOUBRO LIMITED
Date Cleared
2009-06-05
(105 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
**LARSEN **& TOUBRO LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PLANET 55 Model 100 multi-parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2, Respiration, Temperature and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtC02, and FiC02 readings.
In addition, PLANET 55 Model 100 has Arrhythmia and ST detection from 3L / 5L ECG measurements. The Arthythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal Patients.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
Device Description
Planet 55 Model 100 is a Multi-parameter patient monitoring system for continuous monitoring of the physiological parameter ECG (3/5 lead), Arrhythmia & ST analysis, Respiration, NIBP, Temperature, SpO2 and CO2.
PLANET 55 Model 100 is a 4-channel monitor with 8.4" TFT display capable of displaying ECG, Respiration, Sp02, CO2 digital values of HR/PR, Spo2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, FiCO2, FCO2, FCO2 readings. It has selective 24/48/72 Hours tabular and graphical trends. It has special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall first with last 24 patient alarms details. It has a two-channel thermal array recorder for printing of Tabular trends & waveforms. It has got optional communication features i.e. USB, RS232, Infrared remote and Ethernet. The unit comes with adjustable alarm limits as well as visible and audible alarm signals.
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K Number
K082685Device Name
GALAXY 55
Manufacturer
LARSEN & TOUBRO LIMITED
Date Cleared
2008-09-26
(11 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
**LARSEN **& TOUBRO LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Galaxy 55 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2, Respiration, Temperature, Capnography (CO2) & optional Gas module unit. It can also display the digital values of HRPR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, N2O, O2, EtAA and FiAA readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
Device Description
GALAXY 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead). Respiration, NIBP. TBP. Temperature. SpO2. CO2 & Gas monitoring.
GALAXY 55 is a 8-channel monitor with 15"/17"/19" external monitor display capable of displaying ECG. Respiration. SpO2, CO2. digital values of HR/PR. SpO2, RR. Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolie and Mean), Temperature, EiCO2. FiCO2. NoO. On, EiAA and FiAA readings. It has selective 24148172 Hours tabular and graphical trends. It has special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall facility with last 24 patient alarms details. It has a two-channel thermal array recorder for printing of Tabular trends & waveforms. It has got optional communication features -USB. RS232, Infrared remote and Ethernet. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
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K Number
K081552Device Name
SKYLINE 55
Manufacturer
LARSEN & TOUBRO LIMITED
Date Cleared
2008-07-31
(58 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
**LARSEN **& TOUBRO LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K080173Device Name
STAR 55
Manufacturer
LARSEN & TOUBRO LIMITED
Date Cleared
2008-02-08
(15 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
**LARSEN **& TOUBRO LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STAR 55 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2, Respiration, Temperature, Capnography (CO2) & optional Gas module unit. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, N2O, O2, EtAA and FiAA readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
Device Description
STAR 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, IBP, Temperature, Sp02, CO2 & Gas monitoring.
STAR 55 is a 8-channel monitor with 12.1" TFT display capable of displaying ECG, Respiration, SpO2, CO2, digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, N2O, O2, EtAA and FiAA readings. It has selective 24\48\72 Hours tabular and graphical trends. It has special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall facility with last 24 patient alarms details. It has a two-channel thermal array recorder for printing of Tabular trends & waveforms. It has got optional communication features - USB, RS232, Infrared remote and Ethernet. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
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K Number
K071472Device Name
PLANET 55
Manufacturer
LARSEN & TOUBRO LIMITED
Date Cleared
2007-09-21
(115 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
**LARSEN **& TOUBRO LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PLANET 55 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2, Respiration, Temperature and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
Device Description
PLANET 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, Temperature, SpO2, and CO2.
PLANET 55 is a 4-channel monitor with 8.4" TFT display capable of displaying ECG, Respiration, SpO2, CO2, digital values of HR/PR, SpOz, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has selective 24\48\72 Hours tabular and graphical trends. It has special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall facility with last 24 patient alarms details. It has a two-channel thermal array recorder for printing of Tabular trends & waveforms. It has got optional communication features - USB, RS232, RS485 Infrared remote and Ethernet.
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