BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    ZOLL M SERIES SPO2 OPTION

    K Number: K982992 · Decision Mar 11, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    33
    Review Days
    196

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    Basic Information

    Device Name
    ZOLL M SERIES SPO2 OPTION
    K Number
    K982992
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Zoll Medical Corp
    Date Received
    August 27, 1998
    Decision Date
    March 11, 1999
    Product Code
    MKJ
    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
    MKJ Automated External Defibrillators (Non-Wearable)

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    Other Clearances by Zoll Medical Corp

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    K090989 ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
    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
    Search all 33 clearances from Zoll Medical Corp →