BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    MR590 DUAL HOSE HEATER POWER PACK

    K Number: K870055 · Decision Feb 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    12
    Review Days
    34

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    Basic Information

    Device Name
    MR590 DUAL HOSE HEATER POWER PACK
    K Number
    K870055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Fisher & Paykel Allied Products , Ltd.
    Date Received
    January 7, 1987
    Decision Date
    February 10, 1987
    Product Code
    BTT
    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
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Fisher & Paykel Allied Products , Ltd.

    K Number Device Name
    K880702 MODEL MR430 SPECIAL PURPOSE HUMID. HEATER BASES
    K872138 MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER
    K872139 MR420 TRANSPORT HUMIDIFIER
    K863377 MR338 SERVO HEATED DELIVERY HUMIDIFIER
    K862923 MR620 DUAL SERVO HEATED ANAESTHESIA HUMIDIFIER
    K852962 PERIPHERAL NERVE STIMULATOR MODEL A400
    K851879 HEATED RESPIRATORY HUMIDIFIER
    K850647 HEATED RESPIRATORY HUMIFIFIER MR440
    K843903 HEATED RESPIRATORY HUMIDIFIER MR428
    K832928 SERVO HEATED RESPIRATORY HUMIDIFIER
    Search all 12 clearances from Fisher & Paykel Allied Products , Ltd. →