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

    SURFACE TEMPERATURE PROBES

    K Number: K943270 · Decision Dec 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    5
    Review Days
    151

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    Basic Information

    Device Name
    SURFACE TEMPERATURE PROBES
    K Number
    K943270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Coast Medical, Inc.
    Date Received
    July 7, 1994
    Decision Date
    December 5, 1994
    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 Coast Medical, Inc.

    K Number Device Name
    K952243 EXTENSION SET/I.V. SET
    K944729 STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE
    K943495 DISPOSABLE ESOPHAGEAL STETHOSCOPE
    K943110 GAS SAMPLING INTERFACES