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

    SEAMED MODEL 3000

    K Number: K860462 · Decision Aug 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    29
    Applicant Total
    18
    Review Days
    194

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    Basic Information

    Device Name
    SEAMED MODEL 3000
    K Number
    K860462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3630
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Seamed Corp.
    Date Received
    February 6, 1986
    Decision Date
    August 19, 1986
    Product Code
    DTC
    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
    DTC Analyzer, Pacemaker Generator Function

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    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
    K854648 SEAMED MODEL 4000
    K852746 EXTERNAL PACEMAKER TELECTRONICS TE200
    K851900 SEA MED DDD PACING SYSTEM ANALYZER
    Search all 18 clearances from Seamed Corp. →