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

    MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180

    K Number: K101982 · Decision Dec 21, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    160

    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
    MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
    K Number
    K101982
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3720
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    St Jude Medical, Crmd
    Date Received
    July 14, 2010
    Decision Date
    December 21, 2010
    Product Code
    DTA
    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
    DTA Tester, Pacemaker Electrode Function

    Similar 510(k) Clearances

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

    CareLink SmartSync Device Manager - Pacing System Analyzer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADAPTER CABLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODEL EP-2 CLINICAL STIMULATOR

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