BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ARM-A-VIAL LV HEATER-BREATHING SYS

    K Number: K844005 · Decision Nov 8, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    7
    Review Days
    27

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ARM-A-VIAL LV HEATER-BREATHING SYS
    K Number
    K844005
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Armour Pharmaceutical Co.
    Date Received
    October 12, 1984
    Decision Date
    November 8, 1984
    Product Code
    BZE
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BZE), ordered by most recent decision date.

    inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Heated Breathing Tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Armour Pharmaceutical Co.

    K Number Device Name
    K842209 ARM-A-FLOW INTRAVENOUS FLOW REGULATOR
    K841991 ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS
    K841988 ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT
    K841989 ARM-A-VIAL LV SODIUM CHLORIDE INHALAT
    K841987 ARM-A-VIAL LV STERIAL WATER FOR INHALA
    K841990 ARM-A-CARE NEBULIZER-NEBULIZER