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

    CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED

    K Number: K911935 · Decision Jul 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    31
    Review Days
    82

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
    K Number
    K911935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2050
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gould, Inc.
    Date Received
    May 1, 1991
    Decision Date
    July 22, 1991
    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

    CARDIOLAB AMPLIFIER MODULE (CAM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASC-952 PHYSIOLOGICAL AMPLIFIER

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

    Other Clearances by Gould, Inc.

    K Number Device Name
    K861092 MODEL SP1465 CARDIAC OUTPUT COMPUTER
    K860805 PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337
    K855145 MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR
    K854403 MODEL 2120 SPIROSCREEN
    K851486 GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX
    K850114 C/PES 9201, ECG STRESS TESTING SYS
    K850113 C/PES 9103, ECG STRESS TESTING SYSTEM
    K843555 CARDIAC COMPUTER SP1445
    K843969 MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER
    K843970 MODEL IM1074 END-TIDAL CO2 MODULE
    Search all 31 clearances from Gould, Inc. →