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

    SURGERY DISPLAY SYSTEM

    K Number: K800488 · Decision Apr 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    43

    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
    SURGERY DISPLAY SYSTEM
    K Number
    K800488
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2060
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Kent Barker & Assoc.
    Date Received
    March 4, 1980
    Decision Date
    April 16, 1980
    Product Code
    DRQ
    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
    DRQ Amplifier And Signal Conditioner, Transducer Signal

    Similar 510(k) Clearances

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

    ACIST RXi Mini System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER

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