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510(k) Data Aggregation

    K Number
    K040453
    Device Name
    AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
    Manufacturer
    REVIVANT CORP.
    Date Cleared
    2004-03-11

    (17 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    REVIVANT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoPulse™ Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
    Device Description
    AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).
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    K Number
    K032852
    Device Name
    MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
    Manufacturer
    REVIVANT CORP.
    Date Cleared
    2003-11-12

    (61 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    REVIVANT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoPulse™ Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
    Device Description
    AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).
    Ask a Question
    K Number
    K022345
    Device Name
    AUTOPULSE RESUSCITATION SYSTEM
    Manufacturer
    REVIVANT CORP.
    Date Cleared
    2002-08-15

    (27 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    REVIVANT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
    Device Description
    AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).
    Ask a Question
    K Number
    K011046
    Device Name
    AUTOPULSE, MODEL 100
    Manufacturer
    REVIVANT CORP.
    Date Cleared
    2001-10-25

    (202 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    REVIVANT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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