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

    EXTERNAL PACEMAKER TELECTRONICS TE200

    K Number: K852746 · Decision Sep 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    17
    Applicant Total
    18
    Review Days
    77

    Basic Information

    Device Name
    EXTERNAL PACEMAKER TELECTRONICS TE200
    K Number
    K852746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1750
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    SEAMED CORP.
    Date Received
    June 27, 1985
    Decision Date
    September 12, 1985
    Product Code
    JOQ
    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
    JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

    Similar 510(k) Clearances

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

    Bloom2 Programmable Electrophysiology Stimulator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STIMLAB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Z6 STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EP-4 CLINICAL STIMUTATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EP-4 CLINICAL STIMULATOR

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

    Other Clearances by SEAMED CORP.

    K Number Device Name
    K923398 CPI MODEL 2215
    K915364 CHRONOCOR VI MODEL 5012
    K912507 CPI MODEL 2215 & SEAMED MODEL 3400
    K910223 CPI MODEL 2215/SEAMED MODEL 3400
    K883930 SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY
    K872551 SEAMED MODEL 3200
    K863903 SEA MED MODEL 6000
    K860462 SEAMED MODEL 3000
    K854648 SEAMED MODEL 4000
    K851900 SEA MED DDD PACING SYSTEM ANALYZER
    Search all 18 clearances from SEAMED CORP. →