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

    SIGMA 7000 AND SIGMA70002

    K Number: K926191 · Decision Aug 31, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    6
    Review Days
    265

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    Basic Information

    Device Name
    SIGMA 7000 AND SIGMA70002
    K Number
    K926191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sigma
    Date Received
    December 9, 1992
    Decision Date
    August 31, 1993
    Product Code
    FRN
    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
    FRN Pump, Infusion

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    Other Clearances by Sigma

    K Number Device Name
    K962239 SMART ADJUSTER (SA201)
    K851738 MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &
    K851737 MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &
    K830038 SIGMA 7000-6000 INFUSION PUMPS
    K820038 SIGMA 7000