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

    PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM

    K Number: K972255 · Decision Jul 7, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    82
    Applicant Total
    3
    Review Days
    385

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    Basic Information

    Device Name
    PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM
    K Number
    K972255
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pulse Biomedical, Inc.
    Date Received
    June 17, 1997
    Decision Date
    July 7, 1998
    Product Code
    LOS
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

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    Other Clearances by Pulse Biomedical, Inc.

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    K100813 QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
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