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

    SENTRY DISPOSABLE DISPERSIVE ELECTRODE

    K Number: K955636 · Decision Mar 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    35
    Applicant Total
    13
    Review Days
    107

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    Basic Information

    Device Name
    SENTRY DISPOSABLE DISPERSIVE ELECTRODE
    K Number
    K955636
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sentry Medical Products, Inc.
    Date Received
    December 11, 1995
    Decision Date
    March 27, 1996
    Product Code
    JOS
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOS Electrode, Electrosurgical

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    Other Clearances by Sentry Medical Products, Inc.

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    K933603 LEADWIRE
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    K881670 ACCUTEMP PLUS
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    K851522 DIAGNOSTIC ECG DISPOSABLE ELECTRODE
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