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

    TRANSDUCER, PRESSURE, OPTION, H-P, P23ID

    K Number: K780797 · Decision Jun 13, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    31
    Review Days
    29

    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
    TRANSDUCER, PRESSURE, OPTION, H-P, P23ID
    K Number
    K780797
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Gould, Inc.
    Date Received
    May 15, 1978
    Decision Date
    June 13, 1978
    Product Code
    DRS
    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
    DRS Transducer, Blood-Pressure, Extravascular

    Similar 510(k) Clearances

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

    FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Compass Cast and MAP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Disposable Pressure Transducer

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

    Other Clearances by Gould, Inc.

    K Number Device Name
    K911935 CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
    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
    Search all 31 clearances from Gould, Inc. →