Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K011901
    Device Name
    FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
    Manufacturer
    SURVIVALINK CORP.
    Date Cleared
    2002-02-01

    (228 days)

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

    SURVIVALINK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FirstSave STAR Biphasic AED is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy. The device is intended for use on persons older than eight years of age.
    Device Description
    The FirstSave STAR Biphasic AED is a biphasic portable battery operated semiautomatic low power DC defibrillator. The device's diagnostic algorithm analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm. The operator then pushes the button to deliver the defibrillation shock. The FirstSave STAR Biphasic feature includes: Lithium battery, Single user button for Rescue or Resume, LED diagnostic panel, Non-volatile status indicator, Voice prompts, Biphasic truncated exponential defibrillation waveform, RhythmX ECG analysis algorithm.
    Ask a Question
    K Number
    K010214
    Device Name
    FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
    Manufacturer
    SURVIVALINK CORP.
    Date Cleared
    2001-02-22

    (30 days)

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

    SURVIVALINK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K993072
    Device Name
    SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
    Manufacturer
    SURVIVALINK CORP.
    Date Cleared
    1999-12-10

    (87 days)

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

    SURVIVALINK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semi-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for compatibility with the proper electrode connector or adapter. The electrodes are intended for short-term use (< 8 hours) and must be used before the expiration date listed on the packaging. These electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patient skin.
    Device Description
    The SVL-9630 electrodes consists of a pair of non sterile, hydrogel polymeric selfadhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.
    Ask a Question
    K Number
    K982264
    Device Name
    FIRSTSAVE BIPHASIC MODELS 9200 AND 9210
    Manufacturer
    SURVIVALINK CORP.
    Date Cleared
    1999-01-25

    (210 days)

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

    SURVIVALINK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FirstSave STAR Biphasic AED is designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias for patients older than eight years old. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device.
    Device Description
    The FirstSave STAR Biphasic AED is a portable battery operated semi-automatic low power DC defibrillator. The device's diagnostic algorithm analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm. The operator then pushes the button to deliver the defibrillation shock. The FirstSave STAR Biphasic AED feature includes: - . Biphasic defibrillation waveform - . Lithium battery and battery fuel gauge - Single user button . - LED diagnostic panel ● - Non-volatile status indicator ● - Voice prompts . The device weighs 7.4 lbs including battery, and electrodes with dimensions of 3.3in x 10.6in x 12.4in.
    Ask a Question
    K Number
    K970481
    Device Name
    V2
    Manufacturer
    SURVIVALINK CORP.
    Date Cleared
    1997-07-01

    (141 days)

    Product Code
    LDD
    Regulation Number
    870.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURVIVALINK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V2 semi-automatic external defibrillator is designed for emergency treatment of cardiac arrest patients by trained personnel. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device. The V2 is intended to be used on patients who weighs more than 90 lbs.
    Device Description
    FIRST SAVE AUTOMATED EXTERNAL DEFIBRILLATOR (formerly V2) Models 9100/9110
    Ask a Question
    K Number
    K971149
    Device Name
    SVL-9130 DEFIBRILLATION ELECTRODE
    Manufacturer
    SURVIVALINK CORP.
    Date Cleared
    1997-06-23

    (87 days)

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

    SURVIVALINK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SVL-9130 electrodes are single use and intended to be used in conjunction with semi-automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended to be used with AEDs that specify the use of disposable electrodes that meet AAMI DF-39 standards. These AEDs must have compatible electrode connectors. The VivaLink AED and the V2 are examples of such AEDs. The electrodes are intended for short term use and must be used before the expiration date listed on the packaging. The AEDs are used for emergency treatment of cardiac arrest patients who weigh more than 90 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
    Device Description
    The SVL-9130 electrodes consists of a pair of hydrogel polymeric self-adhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.
    Ask a Question

    Page 1 of 1