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510(k) Data Aggregation
K Number
K221141Device Name
PageWriter TC35 Cardiograph
Manufacturer
Medizin Systeme Boblingen GmbH
Date Cleared
2022-12-02
(227 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
Medizin Systeme Boblingen GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PageWriter TC35 Cardiograph is intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze and store these ECG signals for review by the user. It is to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over- read and validate (or change) the computer generated ECG interpretation.
Device Description
The PageWriter TC35 Cardiograph is intended to acquire, record, analyze and store multi-channel ECG signals from adult and pediatric patients through a body surface ECG electrode. The device is integrated with the cleared algorithm (K132068) to provide measurements, and interpretations for review by the clinical on an advisory basis. The interpretated ECG with measurement and interpretative statements are to be used in conjunction with clinician's knowledge of the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over read and validate (or change) the computer-generated ECG interpretation.
PageWriter TC35 Cardiograph has LCD display with touchscreen, keyboard and functional buttons. The device can be powered from AC power or through an embedded re-chargeable battery. The device contains built-in thermal printer for ECG report printing. The device contains USB ports, LAN port and optional WiFi interface for communications.
PageWriter TC35 Cardiograph has various configurations provided for the preference of the user, and it can be updated with the compatible options/modules from the corresponding upgrade Kit (the upgrade kit is not considered as a device kit, refer to the Table 10-2 for the details of configuration list) for use with all approved accessories and spare parts, including patient cables, print papers and trolleys. None of the accessories and spare parts are provided sterile.
Once configured, PageWriter TC35 cardiograph can provides integrated connectivity (wired or wireless) with the compatible Philips IntelliSpace ECG Management System, IntelliBridge Enterprise (IBE), DICOM for patient order download and ECG report transmission. The cybersecurity on PageWriter TC cardiograph is periodically and proactively improved according to the cybersecurity analysis and the routine device cyber maintenance plan.
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K Number
K151736Device Name
Philips IntelliVue GuardianSoftware
Manufacturer
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
Date Cleared
2015-10-21
(117 days)
Product Code
DXJ, DQK, NSX
Regulation Number
870.2450Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntelliVue GuardianSoftware is indicated for use by healthcare providers whenever there is a need for the generation of a patient record.
The IntelliVue GuardianSoftware is intended for use in the collection, storage and management of data from Philips Cableless Measurements and Philips Patient Monitors that are connected through networks.
Device Description
The IntelliVue GuardianSoftware (866009) is a Clinical Information Management System. It collects and manages vital signs data acquired from the IntelliVue Cableless Measurements and IntelliVue Patient Monitors. The IntelliVue GuardianSoftware provides trending, review, reporting, notification, clinical documentation, calculations, clinical advisories including EWS deterioration status, remote viewing and operating, interfacing, storage, and printing. The IntelliVue GuardianSoftware only product. It is intended to be installed on customer supplied compatible off-the shelf information technology equipment that meet the technical requirements as specified by Philips.
The IntelliVue GuardianSoftware can currently acquire physiological data from the following compatible measuring devices:
- Philips IntelliVue Measurements CL SpO2 Pod, CL NBP Pod, CL Resp Pod and l
- Philips IntelliVue Patient Monitors MP5 and MP5SC. -
The subject modification adds the Philips IntelliVue MX400/450 patient monitors and the Philips Suresigns VS3/VS4 patient monitors as additional optional Philips patient monitors to the list of measuring devices compatible with the IntelliVue GuardianSoftware and updates the versions of the supported SQL database versions.
To support the before described purposes the IntelliVue GuardianSoftware was modified to maintain a consistent numbering scheme. The modified common software revision is Rev.C.0
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K Number
K140535Device Name
PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
Manufacturer
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
Date Cleared
2014-11-25
(266 days)
Product Code
HGM, DQA, DRG, DRQ, DRS, DRT, DSA, DSF, DSI, DSJ, DSK, DXG, DXN, DXQ, FLL, HFM, HFN, HGL, JOM, MSX
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Avalon Fetal/Maternal Monitor FM20:
Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.
Avalon Fetal/Maternal Monitor FM30:
Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.
Avalon Fetal/Maternal Monitor FM40:
Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.
Avalon Fetal/Maternal Monitor FM50:
Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.
Device Description
The legally marketed Philips Avalon fetal/maternal monitors FM20. FM30. FM40. and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal electrocardiography (ECG) wave, maternal noninvasive blood pressure (NIBP), oxygen saturation (SpO2) with pulse rate and temperature, during antepartum testing and labor and delivery.
The Avalon Fetal/Maternal Monitor FM20 provides the following external measurement parameters:
- Up to three Fetal Heart Rates (FHR) via Ultrasound (US) -
- Fetal Movement Profile -
- Uterine activity via external Toco -
- -Maternal nulse rate
- -Maternal Heart Rate via maternal ECG
- Noninvasive blood pressure (NBP) -
- Maternal temperature -
- Pulse oximetry (maternal SpO2) -
The Avalon Fetal/Maternal Monitor FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters:
- One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
- -Uterine activity via intrauterine pressure (IUP)
- -Maternal ECG (MECG) wave
*) Note: maximum three fetal heart rates can be monitored.
The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters:
- Up to three Fetal Heart Rates (FHR) via Ultrasound (US) -
- Fetal Movement Profile -
- Uterine activity via external Toco -
- -Maternal Pulse Rate
- Maternal Heart Rate via maternal ECG -
- -Noninvasive blood pressure (NBP)
- -Maternal temperature
- -Pulse oximetry (maternal SpO2)
The Avalon Fetal/Maternal Monitor FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters:
- One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
- Uterine activity via intrauterine pressure (IUP) -
- -Maternal ECG (MECG) wave
*) Note: maximum three fetal heart rates can be monitored.
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K Number
K113657Device Name
INTELLIVUE PATIENT MONITOR
Manufacturer
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
Date Cleared
2012-03-22
(101 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient transport inside and outside of the hospital environment. The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment. The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients. The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only. BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
Device Description
The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MX600, MX700 and MX800 IntelliVue Patient Monitors that consist of display units including built-in or separate flat panel displays and central processing units (CPU) and physiological measurement modules. All monitors share the same system architecture and exactly the same software is executed on each monitor. The IntelliVue Patient Monitors measure multiple physiological parameters such as surface ECG, invasive and non-invasive pressure, etc., generate alarms, record physiological signals, store derived data, and communicate derived data and alarms to central stations via the IntelliVue Clinical Network. The subject modification is enhancement of ProtocolWatch SCC Sepsis protocol by an introduction of configurable thresholds, modification of sepsis criteria and free text fields within the Sepsis Resuscitation Bundle and Sepsis Management Bundle phase of SSC Sepsis protocol. Additionally the software revision J.03 is made available for the entire IntelliVue Patient Monitors family.
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K Number
K102958Device Name
PHILIPS AVALON FETAL MONITOR
Manufacturer
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
Date Cleared
2011-03-18
(165 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Avalon Fetal Monitor FM20: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.
Avalon Fetal Monitor FM30: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.
Avalon Fetal Monitor FM40: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas,
Avalon Fetal Monitor FM50: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.
Device Description
The Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG, maternal non-invasive blood pressure (NIBP) and oxygen saturation (Sp02) with pulse rate, during antepartum testing and labor and delivery.
The Avalon Fetal/Maternal Monitor FM20 provides the following external measurement parameters:
- Up to three Fetal Heart Rates (FHR) via ultrasound (US)
- Fetal Movement Profile
- Uterine activity via external Toco
- Maternal Pulse Rate
- Maternal Heart Rate (MHR) via maternal ECG
- Non-invasive blood pressure (NIBP)
The Avalon FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters:
- Single Fetal Heart Rate via direct ECG (DECG)
- Twin Fetal Heart Rates via direct ECG (DECG) and/or ultrasound
- Uterine activity via intrauterine pressure (IUP)
- Maternal ECG (MECG)
- Pulse oximetry (maternal Sp02).
*) Note: maximum three FHR's can be monitored.
The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters:
- Up to three Fetal Heart Rates (FHR) via ultrasound (US)
- Fetal Movement Profile
- Uterine activity via external Toco
- Maternal Pulse Rate
- Maternal Heart Rate (MHR) via maternal ECG
- Non-invasive blood pressure (NIBP).
- Pulse oximetry (maternal Sp02).
The Avalon FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters:
- Single Fetal Heart Rate via direct ECG *) (DECG)
- Twin Fetal Heart Rates , via direct ECG (DECG) and/or ultrasound "
- Uterine activity via intrauterine pressure , (IUP)
- Maternal ECG (MECG) ,
" Note: maximum three FHR's can be monitored.
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K Number
K090360Device Name
PHILIPS M3001A MULTI MEASUREMENT SERVER
Manufacturer
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
Date Cleared
2009-05-04
(81 days)
Product Code
DQA, DPZ
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment.
Device Description
The modified device Philips M3001A Multi Measurement Server is substantially equivalent to the leqally marketed M3001A Multi Measurement Server (K030973, K033715). The modification consists of the integration of the Nellcor OxiMax SpO2 measurement module which is substantially equivalent to the legally marketed Nellcor OxiMax N-600x Pulse Oximeter (K060576). The modification adds to the M3001A Multi Measurement Server the Nellcor OxiMax SpO2 measurement module as an option in order to use the full Nellcor OxiMax technology. The modification is the integration of the Nellcor OxiMax SpO2 measurement module into the M3001A with minor hardware and software adaptations. The modification leads to a compact Multi measurement Server with integrated full Nelloor OxiMax technology.
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K Number
K083228Device Name
PHILIPS INTELLIVUE MP5 PATIENT MONITOR
Manufacturer
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
Date Cleared
2008-11-24
(21 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment by health care professionals.
Device Description
The modified device Philips IntelliVue MP5 Patient Monitor with Microstream Side Stream CO2 Measurement Module. The modification consists of the integration of the Microstream CO2 Measurement Module, which is substantial equivalent to the legally marketed Philips M3015A Measurement Server Extension (k993383) and to the Oridion Capnostream2o with A2 Adaptive Averaging Software and Extended CO2 Measurement Range (k072295).
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