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510(k) Data Aggregation

    K Number
    K080391
    Device Name
    DRIVE SOLSTICE OXYGEN CONCENTRATOR
    Manufacturer
    MEDICAL DEPOT
    Date Cleared
    2008-03-18

    (34 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEPOT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended function and use of the Drive Solistice Oxygen Concentrator (models 18050 and 18055) is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
    Device Description
    The Drive Solstice Oxygen Concentrator is a PSA (Pressure Swing Adsorption) system Oxygen Concentrator, the output of oxygen is 1 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of the adsorption material -molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed top. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient. At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the top of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 90% oxygen to the patient.
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    K Number
    K012006
    Device Name
    MEDICAL DEPOT POWER NEB 1
    Manufacturer
    MEDICAL DEPOT, INC.
    Date Cleared
    2001-07-13

    (16 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEPOT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Depot is intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.
    Device Description
    The Medical Depot Nebulizer Device is the same as our Power Neb II except with a membrane rather than a piston compressor. It is also the same as the Graham - Field Mini-Mist II which was originally cleared by John Bunn Company and has the same compressor as this device.
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    K Number
    K003344
    Device Name
    MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
    Manufacturer
    MEDICAL DEPOT, INC.
    Date Cleared
    2001-03-15

    (141 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEPOT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003783
    Device Name
    MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER
    Manufacturer
    MEDICAL DEPOT, INC.
    Date Cleared
    2001-01-12

    (36 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEPOT, INC

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