BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE

    K Number: K972970 · Decision Aug 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    55
    Review Days
    16

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
    K Number
    K972970
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Graphic Controls Corp.
    Date Received
    August 11, 1997
    Decision Date
    August 27, 1997
    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)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MKJ), ordered by most recent decision date.

    Powerheart G5 AED

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OneStep Pediatric CPR Multi-Function Electrode

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    samaritan PAD 450P

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZOLL E SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular
    View all

    Other Clearances by Graphic Controls Corp.

    K Number Device Name
    K981964 MEDI-TRACE 4103 NEONATAL ELECTRODE
    K983287 MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
    K974730 SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
    K980857 MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
    K964387 POINT OF USE II SHARPS-A-GATOR
    K964279 SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
    K963151 MEDI-TRACE 5700 RESTING ECG ELECTRODE
    K963038 MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
    K960968 MEDI-TRACE 200, MEDI-TRACE 200-30
    K955882 MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS
    Search all 55 clearances from Graphic Controls Corp. →