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

    AS/3 CARDIAC OUTPUT & SVO2 MODULE

    K Number: K961063 · Decision May 31, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    403
    Applicant Total
    5
    Review Days
    74

    Basic Information

    Device Name
    AS/3 CARDIAC OUTPUT & SVO2 MODULE
    K Number
    K961063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DATEX MEDICAL INSTRUMENTATION, INC.
    Date Received
    March 18, 1996
    Decision Date
    May 31, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DQK), ordered by most recent decision date.

    Globe® Pulsed Field System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PhysCade System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptiMap™ System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DeepRhythmAI

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Volta AF-Xplorer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VitalRhythm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by DATEX MEDICAL INSTRUMENTATION, INC.

    K Number Device Name
    K955026 AS/3 NMT MODULE
    K960490 AS/3 COMPACT AIRWAY MODULE M-CAIOV
    K953006 AS/3 NETWORK LINK
    K912530 CARDIOCAP II(TM)