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

    DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING

    K Number: K951345 · Decision Apr 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    167
    Registration Numbers
    167
    Same Product Code
    93
    Applicant Total
    8
    Review Days
    22

    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
    DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING
    K Number
    K951345
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5810
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Catheter Research, Inc.
    Date Received
    March 23, 1995
    Decision Date
    April 14, 1995
    Product Code
    BZA
    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
    BZA Connector, Airway (Extension)

    Similar 510(k) Clearances

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

    TRACH-ASSIST

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SURELOC CIRCUIT CONNECTOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    DISPOSABLE FLEX TUBE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA, INC. VENTILATOR HOSES

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

    Other Clearances by Catheter Research, Inc.

    K Number Device Name
    K123258 THE ADVANCE CATHETER FOR HSG AND SIS
    K120154 INTRAUTERINE INSEMINATION (IUI) CATHETER
    K032835 H/S CATHETER SET
    K020292 UTERINE INJECTOR
    K973839 DISPOSABLE ESOPHAGEAL STETHOSCOPE
    K974357 UTERINE MANIPULATOR/INJECTOR
    K946044 DISPOSABLE GAS SAMPLING LINES