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

    DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.

    K Number: K894355 · Decision Dec 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    2
    Review Days
    151

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    Basic Information

    Device Name
    DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.
    K Number
    K894355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Phycon
    Date Received
    July 14, 1989
    Decision Date
    December 12, 1989
    Product Code
    LDD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

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    Other Clearances by Phycon

    K Number Device Name
    K894356 DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.