Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K063510
    Device Name
    LIFEPAK 12 DEFIBRILLATOR/MONITOR
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
    Date Cleared
    2007-01-26

    (67 days)

    Product Code
    MKJ, CCK, DQA, DRO, DRT, DSK, DXN, LDD
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Manual Defibrillation: Indications Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. Contraindications Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole. Automated External Defibrillation: Indications AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old. Noninvasive Pacing: Indications Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse. Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole. 12-lead Electrocardiography: Indications The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction. Pulse Oximetry: Indications Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia. Noninvasive Blood Pressure Monitoring: Indications Noninvasive blood pressure monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibrillation recovery analysis. End-Tidal CO2 monitoring: Indications EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully. It is intended for use on adult and pediatric patients. Invasive Pressure Monitoring: Indications The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system with a compatible transducer. It may be used on the adult or pediatric patient.
    Device Description
    The LIFEPAK 12 defibrillator/monitor was designed for use in a variety of hospital and pre-hospital settings including emergency departments, critical care areas, and air and ground ambulances. The LIFEPAK 12 defibrillator/monitor is powered by either a battery or AC power. LIFEPAK 12 defibrillator/monitor features include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry, synchronized cardioversion. noninvasive blood pressure monitoring, end-tidal CO2 monitoring, and invasive pressure monitoring. The LIFEPAK 12 defibrillator/monitor has been modified with new setup options in automated external defibrillation (AED) mode to give medical directors or physicians flexibility in establishing their AED protocols including consistency with the recently updated 2005 AHA Guidelines for CPR and ECC.
    Ask a Question
    K Number
    K063119
    Device Name
    LIFEPAK 20 DEFIBRILLATOR/ MONITOR
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
    Date Cleared
    2006-12-22

    (71 days)

    Product Code
    MKJ, DQA, DRO, DRT, LDD
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Manual Defibrillation: Indications: Defibrillation is a recognized means of terminating certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular escape rhythms, and in the treatment of asystole. Automated External Defibrillation: Indications: The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. Noninvasive Pacing Indications: Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse. Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole. Pulse Oximetry Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.
    Device Description
    The LIFEPAK 20 defibrillator/monitor was created especially for hospitals and clinics for use on "crash carts" as well as for portable emergency response throughout a hospital. The LIFEPAK 20 defibrillator/monitor is equipped with AC power and a backup internal battery. Features of the LIFEPAK 20 defibrillator/monitor include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-wire or 5-wire), pulse oximetry, and synchronized cardioversion. The LIFEPAK 20 defibrillator/monitor has been modified with new setup options in automated external defibrillation (AED) mode to give medical directors or physicians flexibility in establishing their AED protocols including consistency with the recently updated 2005 AHA Guidelines for CPR and ECC.
    Ask a Question
    K Number
    K052057
    Device Name
    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
    Date Cleared
    2006-02-17

    (203 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIFEPAK 500 AED is intended for use on patients in cardiac arrest. It is intended for use in hospital and in out-of-hospital environments. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a medical director and have, at a minimum, the following skills and training: - CPR training - AED training equivalent to that recommended by the American Heart Association - Training in the use of the LIFEPAK 500 AED The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient's ECG rhythm. With Infant/Child Reduced Energy Defibrillation Electrodes, the specially configured biphasic LIFEPAK 500 AED may be used on children up to 8 years old or 25kg (55 lb).
    Device Description
    The LIFEPAK 500 automated external defibrillator is a small, portable, battery operated device intended for treatment of cardiac arrest. The device uses a patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present. The LIFEPAK 500 AED will inform the operator if it detects a shockable rhythm and the operator can press the shock button to deliver energy. The energy is delivered via disposable defibrillation electrodes applied to the chest.
    Ask a Question
    K Number
    K052854
    Device Name
    LIFENET EXCHANGE SYSTEM
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
    Date Cleared
    2006-01-20

    (101 days)

    Product Code
    MSX
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIFENET Exchange System is an optional data transmission system that provides the capability to transmit 12-Lead ECG reports and other physiological data to a receiving device at a remote location. Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.
    Device Description
    The LIFENET® Exchange System is an optional data transmission system that provides the capability to transmit 12-Lead ECG reports and other physiological data to a receiving device at a remote location. Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.
    Ask a Question
    K Number
    K042404
    Device Name
    LIFEPAK, MODEL 1000
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
    Date Cleared
    2005-12-22

    (475 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25 kg (55 lbs) with Infant/Child Reduced Energy Defibrillation Electrodes. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.
    Device Description
    The LIFEPAK 1000 defibrillator is a semi-automatic defibrillator with manual mode and ECG mode available as options. The manual mode allows a caregiver skilled in rhythm recognition to switch to manual mode and treat the patient without relying on the automated analysis feature and without connecting a separate defibrillator. Features and options of the LIFEPAK 1000 defibrillator include: ECG rhythm and heart rate monitoring using defibrillation electrodes or using an ECG cable with monitoring electrodes, data transmission via serial infrared link, power via non-rechargeable lithium manganese battery, and configurable voice prompts.
    Ask a Question
    K Number
    K041459
    Device Name
    LIFEPAK 12 DEFIBRILLATOR/MONITOR
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
    Date Cleared
    2004-07-01

    (29 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old. Manual Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. Noninvasive Pacing is indicated for patients with symptomatic bradycardia or asystole. 12-Lead Electrocardiography is useful in the early detection and prompt treatment of patients with acute myocardial infarction. Pulse Oximetry is used to check the saturation of oxygen in arterial blood. It is indicated for use in any patient who is at risk of developing hypoxemia. Noninvasive Blood Pressure Monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibrillation recovery analysis. End-Tidal CO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully. Invasive Pressure Monitoring is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using an invasive catheter system with a compatible transducer.
    Device Description
    The LIFEPAK 12 defibrillator/monitor is a complete acute cardiac response system, which consists of a battery or auxiliary powered defibrillator (manual or automated), external pacemaker, ECG monitor (3-lead, 5-lead and interpretive 12-Lead), pulse oximeter, noninvasive blood pressure monitor, end-tidal CO2 monitor, and invasive pressure monitor. Patient data can be transmitted from the LIFEPAK 12 defibrillator to a fax machine, computer, or to a receiving station. This modification changes the pulse oximetry module and sensors used in the LIFEPAK 12 defibrillator/monitor from Nellcor to Masimo.
    Ask a Question

    Page 1 of 1