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

    AMBULATORY (HOLTER) RECORDING SYSTEM

    K Number: K950944 · Decision Jun 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    10
    Review Days
    487

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    Basic Information

    Device Name
    AMBULATORY (HOLTER) RECORDING SYSTEM
    K Number
    K950944
    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
    February 17, 1995
    Decision Date
    June 18, 1996
    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
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    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