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

    THERMAL PROBE COVER

    K Number: K915831 · Decision Jun 8, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    91
    Applicant Total
    9
    Review Days
    161

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    Basic Information

    Device Name
    THERMAL PROBE COVER
    K Number
    K915831
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5130
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vermont Medical, Inc.
    Date Received
    December 30, 1991
    Decision Date
    June 8, 1992
    Product Code
    FMT
    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
    FMT Warmer, Infant Radiant

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    Other Clearances by Vermont Medical, Inc.

    K Number Device Name
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    K010638 NEUROPLUS, MODEL A10040, A10041, A10042, A10043
    K921498 VER MED A10011 PNS DUAL ELEMENT ELECTRODE
    K911687 VER-MED A10020 RESTING EKG ELECTRODE
    K910139 VER-MED A10014 RESTING EKG ELECTRODE & A10021
    K905489 VER-MED A10017 UNIVERSAL ELECTRODE
    K781430 PREGELLED DISPOSABLE E.K.G. ELECTRODE