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

    PACE-1A CARDIAC STIMULATOR

    K Number: K963579 · Decision Nov 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    17
    Applicant Total
    56
    Review Days
    63

    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
    PACE-1A CARDIAC STIMULATOR
    K Number
    K963579
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1750
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radionics, Inc.
    Date Received
    September 6, 1996
    Decision Date
    November 8, 1996
    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 Radionics, Inc.

    K Number Device Name
    K030697 RADIONICS SINGLE USE GROUND PAD (DGP-HP)
    K001741 RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
    K002773 NEUROMAP WITH NEURO 100
    K992226 XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
    K001950 OPTICAL TRACKING SYSTEM (OTS)
    K001700 XPLAN 2.1
    K001431 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
    K000057 RADIONICS LUMBOPERITONEAL SHUNT
    K993594 CONFORMAX MMLC VR1
    K991399 RADIONICS MICROELECTRODE KIT
    Search all 56 clearances from Radionics, Inc. →