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

    BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER

    K Number: K032432 · Decision Aug 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    31
    Review Days
    22

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    Basic Information

    Device Name
    BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
    K Number
    K032432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2500
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Busse Hospital Disposables, Inc.
    Date Received
    August 6, 2003
    Decision Date
    August 28, 2003
    Product Code
    FMJ
    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
    FMJ Manometer, Spinal-Fluid

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    Other Clearances by Busse Hospital Disposables, Inc.

    K Number Device Name
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    K093909 BUSSE SURGICAL DRAPES IV
    K092212 BUSSE SURGICAL DRAPES III
    K082297 BUSSE SURGICAL DRAPE
    K073222 MODIFICATION TO:SPECIALTY NEEDLES
    K070465 BUSSE EPIDURAL CATHETER
    K063018 GLASS LOSS OF RESISTANCE SYRINGE
    K061394 SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
    K061570 I-STYLE BONE MARROW ASPIRATION NEEDLE
    K052843 BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
    Search all 31 clearances from Busse Hospital Disposables, Inc. →