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

    PACER SENSING ANALYZER (PSA 100)

    K Number: K882327 · Decision Oct 6, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    29
    Applicant Total
    31
    Review Days
    122

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    Basic Information

    Device Name
    PACER SENSING ANALYZER (PSA 100)
    K Number
    K882327
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3630
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Oscor Medical Corp.
    Date Received
    June 6, 1988
    Decision Date
    October 6, 1988
    Product Code
    DTC
    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
    DTC Analyzer, Pacemaker Generator Function

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    Other Clearances by Oscor Medical Corp.

    K Number Device Name
    K964107 OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR
    K925168 MISCELLANEOUS PACING LEAD
    K923621 EXTERNAL DEMAND PACEMAKER
    K912867 OSCOR MEDICAL CORP PERMANENT PACING LEAD
    K915007 PERMANENT PACING LEADS, MODIFICATION
    K915008 PERMANENT PACING PAD, MODIFICATION
    K913204 MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION
    K913158 MODIFIED OSCOR PY PACING LEADS/MODIFICATION
    K913202 IMPLANT PACING LEAD, TINED #3262, MODIFICATION
    K913203 IMPLANT PACING LEAD TINED #3390, MODIFICATION
    Search all 31 clearances from Oscor Medical Corp. →