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

    TEMP-CHECK ADAPTOR, Y-CONFIGURATION

    K Number: K830921 · Decision May 2, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    87
    Applicant Total
    5
    Review Days
    41

    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
    TEMP-CHECK ADAPTOR, Y-CONFIGURATION
    K Number
    K830921
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Cygnus Research Corp.
    Date Received
    March 22, 1983
    Decision Date
    May 2, 1983
    Product Code
    BZO
    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
    BZO Set, Tubing And Support, Ventilator (W Harness)

    Similar 510(k) Clearances

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

    UNICOR, INC. CORRUGATED TUBING

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    UNICOR, INC. VENTILATOR HOSES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA VENTILATOR HOSES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA CUSTOM ANESTESIA CIRCUIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA BREATHING BAGS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA VOLUMN VENTILATORSS

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

    Other Clearances by Cygnus Research Corp.

    K Number Device Name
    K831556 VAPOR-PHASE HUMIDIFIER SYSTEM
    K831163 LO-COMP RESERVOIR-RE-1000
    K830923 TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA
    K830922 TEMP-CHECK ADAPTOR, TEE-CONFIGURATION