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

    CLOUD 1 HUMIDIFICATION SYSTEM

    K Number: K983862 · Decision May 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    27
    Review Days
    203

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    Basic Information

    Device Name
    CLOUD 1 HUMIDIFICATION SYSTEM
    K Number
    K983862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Respiratory Support Products, Inc.
    Date Received
    November 2, 1998
    Decision Date
    May 24, 1999
    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 Respiratory Support Products, Inc.

    K Number Device Name
    K921190 ADAP-TEMP TEMPERATURE SENSOR ADAPTER
    K920469 MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE
    K921510 GAS SAMPLING KIT MODIFICATION
    K913082 BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D
    K913083 BI-TEMP TEMPERATURE MONITOR TM-201D
    K912280 BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D
    K903816 URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
    K874694 ADAP-TEMP, MODEL: AT-100
    K873472 MEMBRANE HUMIDIFIER
    K873205 TYMPANIC TEMPERATURE SENSOR
    Search all 27 clearances from Respiratory Support Products, Inc. →