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

    TRI-PLEX ADAPTER

    K Number: K010401 · Decision Oct 30, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    625

    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
    TRI-PLEX ADAPTER
    K Number
    K010401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Medical Device Group, Inc.
    Date Received
    February 12, 2001
    Decision Date
    October 30, 2002
    Product Code
    MOD
    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
    MOD Accessory To Continuous Ventilator (Respirator)

    Similar 510(k) Clearances

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

    CorVision® (91-205-Z0014)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EveryWare

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Care Cycle Connect Application

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VENTLINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    IISIS, VERSION 1.0

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