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

    BIOSENSOR HOLTER MONITOR SYSTEM

    K Number: K974546 · Decision Mar 4, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    10
    Review Days
    90

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    Basic Information

    Device Name
    BIOSENSOR HOLTER MONITOR SYSTEM
    K Number
    K974546
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biosensor Corp.
    Date Received
    December 4, 1997
    Decision Date
    March 4, 1998
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Biosensor Corp.

    K Number Device Name
    K990956 BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005
    K974192 BIOSENSOR HOLTER MONITOR SYSTEM
    K950944 AMBULATORY (HOLTER) RECORDING SYSTEM
    K960449 PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)
    K943338 BIOSENSOR BIDOP VASCULAR TEST SYSTEM
    K950723 AMBULATORY (HOLTER) RECORDING SYSTEM
    K922027 AMBULATORY (HOLTER) RECORDING, MODIFICATION
    K895266 AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED
    K831676 BIOSENSOR ASC SYSTEM