BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ENDOTRACHEAL TUBE HOLDER

    K Number: K802675 · Decision Nov 19, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    18
    Applicant Total
    27
    Review Days
    21

    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
    ENDOTRACHEAL TUBE HOLDER
    K Number
    K802675
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5280
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Respiratory Support Products, Inc.
    Date Received
    October 29, 1980
    Decision Date
    November 19, 1980
    Product Code
    JAY
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JAY Support, Breathing Tube

    Similar 510(k) Clearances

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

    CUSTOM MEDICAL SUSPENSION STRAP

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    BLOCK, BITE, INTUBATION

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    JEE FRAME (VENTILATOR CIRCUIT SUPPORT)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ENDO-SECURE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all

    Other Clearances by Respiratory Support Products, Inc.

    K Number Device Name
    K983862 CLOUD 1 HUMIDIFICATION SYSTEM
    K921190 ADAP-TEMP TEMPERATURE SENSOR ADAPTER
    K920469 MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE
    K921510 GAS SAMPLING KIT MODIFICATION
    K913082 BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D
    K913083 BI-TEMP TEMPERATURE MONITOR TM-201D
    K912280 BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D
    K903816 URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
    K874694 ADAP-TEMP, MODEL: AT-100
    K873472 MEMBRANE HUMIDIFIER
    Search all 27 clearances from Respiratory Support Products, Inc. →