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

    THE TELESCAN C.A.R.E. SYSTEM

    K Number: K871587 · Decision Aug 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    5
    Review Days
    110

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    Basic Information

    Device Name
    THE TELESCAN C.A.R.E. SYSTEM
    K Number
    K871587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Telescan Medical Systems
    Date Received
    April 24, 1987
    Decision Date
    August 12, 1987
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

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    Other Clearances by Telescan Medical Systems

    K Number Device Name
    K942586 CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)
    K924187 INSTANT MEMORY 2000
    K883358 TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM
    K820276 TELESCAN T-30