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

    LIFEBORNE INFANT RESUSCITATOR

    K Number: K140707 · Decision May 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    8
    Review Days
    69

    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
    LIFEBORNE INFANT RESUSCITATOR
    K Number
    K140707
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Biomedical
    Date Received
    March 20, 2014
    Decision Date
    May 28, 2014
    Product Code
    BTL
    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
    BTL Ventilator, Emergency, Powered (Resuscitator)

    Similar 510(k) Clearances

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

    VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oxymag - Transport and Emergency Ventilator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VORTRAN GO2VENT with PEEP Valve

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Puffin Lite Infant Resuscitation System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SafeT T-Piece Resuscitator

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

    Other Clearances by International Biomedical

    K Number Device Name
    K221154 Infant Heel WarmerTM; Heel Snuggler®
    K221653 InfaTherm Disposable Infant Warming Mattress
    K220742 NxtGen Infant Transport Incubator
    K193481 AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
    K182956 Puffin Lite Infant Resuscitation System
    K173516 NuBorne Infant Warmer
    K160238 Airborne Phototherapy Light