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

    GOULD XCALIBER

    K Number: K862344 · Decision Aug 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    37
    Review Days
    47

    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
    GOULD XCALIBER
    K Number
    K862344
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bio-Tek Instruments, Inc.
    Date Received
    June 20, 1986
    Decision Date
    August 6, 1986
    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 Bio-Tek Instruments, Inc.

    K Number Device Name
    K973609 IDA-4 AND IPT-MC
    K971273 INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF
    K961862 MODELS IDA-2 PLUS AND IPT-1
    K954391 MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
    K953710 ELX808 AUTOMATED MICROPLATE READERS
    K953572 ELX800UV
    K950104 ELX800 AND EL800 AUTOMATED MICROPLATE READERS
    K942923 CERES 900C & CERES UV900C
    K944257 LIONHEART 3 MULTI-PARAMETER SIMULATOR
    K933519 INDEX SPO2 SIMULATOR
    Search all 37 clearances from Bio-Tek Instruments, Inc. →