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

    ZOLL AUTOCLAVABLE INTERNAL HANDLES

    K Number: K963781 · Decision May 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    33
    Review Days
    242

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    Basic Information

    Device Name
    ZOLL AUTOCLAVABLE INTERNAL HANDLES
    K Number
    K963781
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Zoll Medical Corp
    Date Received
    September 20, 1996
    Decision Date
    May 20, 1997
    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 Zoll Medical Corp

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    K042007 ZOLL E SERIES DEFIBRILLATOR
    K042302 ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE
    K042417 ZOLL M SERIES ETC02 LOFLO OPTION
    K033474 ZOLL AED PLUS
    K032691 ZOLL AUTOCLAVABLE INTERNAL HANDLES
    K032439 ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
    K032363 ZOLL M SERIES NIBP OPTION
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