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

    MODEL 15055A MAINFRAME

    K Number: K791964 · Decision Oct 11, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    230
    Review Days
    10

    Basic Information

    Device Name
    MODEL 15055A MAINFRAME
    K Number
    K791964
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2050
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    HEWLETT-PACKARD CO.
    Date Received
    October 1, 1979
    Decision Date
    October 11, 1979
    Product Code
    DRR
    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
    DRR Amplifier And Signal Conditioner, Biopotential

    Similar 510(k) Clearances

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

    BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EP AMP, MODEL #901

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HORIZON 9000/HIS OPTION AMPLIFIER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIOLAB AMPLIFIER MODULE (CAM)

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

    Other Clearances by HEWLETT-PACKARD CO.

    K Number Device Name
    K992543 HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE
    K993587 HP M2376A DEVICE LINK SYSTEM
    K993169 MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
    K992977 HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
    K993516 HP M2600A VIRIDIA TELEMETRY SYSTEM
    K993171 HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
    K992636 HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
    K991871 HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
    K984194 HP M2376A DEVICE LINK SYSTEM
    K990400 LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM
    Search all 230 clearances from HEWLETT-PACKARD CO. →