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

    OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES

    K Number: K022939 · Decision Oct 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    64
    Applicant Total
    7
    Review Days
    29

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    Basic Information

    Device Name
    OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
    K Number
    K022939
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3600
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osypka Medical, Inc.
    Date Received
    September 4, 2002
    Decision Date
    October 3, 2002
    Product Code
    DTE
    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
    DTE Pulse-Generator, Pacemaker, External

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    Other Clearances by Osypka Medical, Inc.

    K Number Device Name
    K123916 PSA SERIES
    K082242 ICON, MODEL C3
    K081035 AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
    K070985 AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
    K033130 PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
    K020896 OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE