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510(k) Data Aggregation

    K Number
    K131098
    Device Name
    EMERGENCY PORTABLE VENTILATOR
    Date Cleared
    2014-04-09

    (356 days)

    Product Code
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AHP300P is intended to be used as an electrically controlled emergency ventilator that requires an external compressed gas source. This ventilator is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway. The ventilator is intended for use on patients weighing greater than 5kg (11 lbs). The ventilator is intended to be used in the environments associated with emergency medical services (EMS), Inter-hospital transport and hospital facilities usage. The ventilator is intended to be used in temperatures of -18 C to 50 C (0 F to 122 F) and 5% to 95 % relative humidity non-condensing.
    Device Description
    Not Found
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    K Number
    K132021
    Device Name
    AHP 300, EMERGENCY PORTABLE VENTILATOR
    Date Cleared
    2014-04-02

    (274 days)

    Product Code
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AHP300 (with internal compressor) is intended to be used as an electrically controlled emergency ventilator. This ventilator is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patient's airway. The ventilator is intended for use on patients weighing greater than 5kg (11 1bs). The ventilator is intended to be used in the environments associated with emergency medical services (EMS), inter-hospital transport and hospital facilities usage by qualified, trained personnel under the direction of a physician. The ventilator is intended to be used in temperatures of -18 C to 50 C (0 F to 122 F) and 5% to 95% relative humidity non-condensing.
    Device Description
    Not Found
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    K Number
    K111139
    Device Name
    DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U
    Date Cleared
    2011-09-02

    (133 days)

    Product Code
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANSELL HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
    Device Description
    The Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs, is a disposable device made of synthetic latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs. A coating of Aliphatic Polyester Polyurethane is applied to the inner surface of the glove to make donning easy.
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    K Number
    K090356
    Device Name
    EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
    Date Cleared
    2009-05-20

    (97 days)

    Product Code
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K083507
    Device Name
    BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
    Date Cleared
    2009-05-18

    (173 days)

    Product Code
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K083385
    Device Name
    MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
    Date Cleared
    2009-05-14

    (178 days)

    Product Code
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K082457
    Device Name
    MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
    Date Cleared
    2008-11-10

    (76 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANSELL HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
    Device Description
    Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005). Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application. Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs. Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards. | Characteristics | Standard | |--------------------------------------------------------------------------------------------------|-----------------------------------------------------| | Dimensions | Meets ASTM D 6319-00a(2005) | | Physical Properties | Meets ASTM D 6319-00a(2005) | | Freedom from Holes | Meets ASTM D 6319-00a(2005)<br>Meets ASTM D 5151-06 | | Powder-Free | Powder content ≤ 2 mg per glove | | Biocompatibility:<br>ISO Skin Irritation Study<br>ISO Maximization Sensitization Study - Extract | No irritation<br>No irritation |
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    K Number
    K080063
    Device Name
    MASS CASUALTY VENTILATOR, MODEL MCV100
    Date Cleared
    2008-08-15

    (218 days)

    Product Code
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MCV100 and MCV100-B are intended to be used as an electrically controlled, electrical / gas powered emergency ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway.
    Device Description
    Not Found
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    K Number
    K072214
    Device Name
    PORTABLE VENTILATOR, MODEL EPV-100
    Date Cleared
    2008-03-06

    (210 days)

    Product Code
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EPV100 is intended to be used as an electronically controlled gas powered emergency ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patient's airway. The ventilator is intended for use on patients weighing greater than 20kg (44 lbs). This ventilator is intended to be used in the environments associated with emergency medical services (EMS), interhospital transport and hospital facility usage.
    Device Description
    Not Found
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    K Number
    K073171
    Device Name
    RESUSCITATION TIMER, MODEL L770-CPR
    Date Cleared
    2008-01-31

    (83 days)

    Product Code
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLIED HEALTHCARE PRODUCTS, INC.

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