BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    MODELS IDA-2 PLUS AND IPT-1

    K Number: K961862 · Decision Feb 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    37
    Review Days
    288

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    Basic Information

    Device Name
    MODELS IDA-2 PLUS AND IPT-1
    K Number
    K961862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Bio-Tek Instruments, Inc.
    Date Received
    May 14, 1996
    Decision Date
    February 26, 1997
    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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