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

    INSTRUMENT WARMER

    K Number: K925530 · Decision Jun 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    26
    Applicant Total
    14
    Review Days
    228

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    Basic Information

    Device Name
    INSTRUMENT WARMER
    K Number
    K925530
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5140
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Superior Healthcare Group, Inc.
    Date Received
    November 2, 1992
    Decision Date
    June 18, 1993
    Product Code
    FMS
    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
    FMS Bed, Pediatric Open Hospital

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    Other Clearances by Superior Healthcare Group, Inc.

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    K891445 LATEX EXAMINATION GLOVES
    K892426 NO. 86500 - ENDOSCOPIC JET WASHER
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