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

    SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606

    K Number: K981800 · Decision Jul 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    2
    Review Days
    46

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    Basic Information

    Device Name
    SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606
    K Number
    K981800
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Equal Diagnostics, Inc.
    Date Received
    May 21, 1998
    Decision Date
    July 6, 1998
    Product Code
    HIH
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIH Hysteroscope (And Accessories)

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    Other Clearances by Equal Diagnostics, Inc.

    K Number Device Name
    K961179 SENTINEL LIPASE LIQUID MODEL 17.401B