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

    TRANS-PACE 100

    K Number: K900220 · Decision Jul 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    64
    Applicant Total
    1
    Review Days
    181

    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
    TRANS-PACE 100
    K Number
    K900220
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3600
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Synchromed Corp.
    Date Received
    January 17, 1990
    Decision Date
    July 17, 1990
    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

    Similar 510(k) Clearances

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

    Solo Pace Control

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Lifetech Cardio Temporary Pacemaker

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medtronic Model 5392 External Pulse Generator (EPG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medtronic Model 5392 External Pulse Generator (EPG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Lifetech Cardio Model 8301 Temporary Pacemaker

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medtronic Model 5392 External Pulse Generator (EPG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all