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

    MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE

    K Number: K873206 · Decision Sep 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    16
    Applicant Total
    27
    Review Days
    47

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    Basic Information

    Device Name
    MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE
    K Number
    K873206
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Respiratory Support Products, Inc.
    Date Received
    August 14, 1987
    Decision Date
    September 30, 1987
    Product Code
    DTW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

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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
    K874694 ADAP-TEMP, MODEL: AT-100
    K873472 MEMBRANE HUMIDIFIER
    Search all 27 clearances from Respiratory Support Products, Inc. →