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

    PROBE COVER

    K Number: K810474 · Decision Mar 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    19
    Review Days
    36

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    Basic Information

    Device Name
    PROBE COVER
    K Number
    K810474
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Narco Air-Shields
    Date Received
    February 23, 1981
    Decision Date
    March 31, 1981
    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 Narco Air-Shields

    K Number Device Name
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    K802126 ISOLETTE INCUBATOR C-100
    K792592 AMBU UNIVERSAL SUCTION PUMP
    K792499 AMBU PAEDI ANAESTHESIA SYSTEM
    K792117 AIR-SHIELDS HEART RATE MONITOR
    K792118 AIR-SHIELDS RESUSCITATORS
    K790552 AS7 & AS8 MONITORS
    K790551 TRANSPORT INCUBATOR
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