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

    DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES

    K Number: K070339 · Decision Sep 26, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    12
    Review Days
    233

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    Basic Information

    Device Name
    DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES
    K Number
    K070339
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cincinnati Sub-Zero Products, Inc.
    Date Received
    February 5, 2007
    Decision Date
    September 26, 2007
    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 Cincinnati Sub-Zero Products, Inc.

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    K110104 BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
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    K072621 ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
    K942790 WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133)
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