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

    ADAP-TEMP, MODEL: AT-100

    K Number: K874694 · Decision Mar 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    27
    Review Days
    109

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    Basic Information

    Device Name
    ADAP-TEMP, MODEL: AT-100
    K Number
    K874694
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Respiratory Support Products, Inc.
    Date Received
    November 13, 1987
    Decision Date
    March 1, 1988
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Respiratory Support Products, Inc.

    K Number Device Name
    K983862 CLOUD 1 HUMIDIFICATION SYSTEM
    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
    K873472 MEMBRANE HUMIDIFIER
    K873205 TYMPANIC TEMPERATURE SENSOR
    Search all 27 clearances from Respiratory Support Products, Inc. →