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510(k) Data Aggregation

    K Number
    K131098
    Device Name
    EMERGENCY PORTABLE VENTILATOR
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2014-04-09

    (356 days)

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

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2014-04-02

    (274 days)

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

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    K090356
    Device Name
    EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2009-05-20

    (97 days)

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

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K083507
    Device Name
    BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2009-05-18

    (173 days)

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

    ALLIED HEALTHCARE PRODUCTS, INC.

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

    (178 days)

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

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K080063
    Device Name
    MASS CASUALTY VENTILATOR, MODEL MCV100
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2008-08-15

    (218 days)

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

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2008-03-06

    (210 days)

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

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2008-01-31

    (83 days)

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

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K070636
    Device Name
    AUTOVENT 4000 WITH CPAP
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2007-07-13

    (128 days)

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

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K070120
    Device Name
    AUTOVENT MODEL 4000
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2007-05-03

    (111 days)

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

    ALLIED HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Autovent 4000 is a powered emergency transport ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway.
    Device Description
    Autovent 4000
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