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

    LIFEGUARD MOUTH TO MASK RESUSCITATOR

    K Number: K881086 · Decision Apr 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    12
    Review Days
    31

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    Basic Information

    Device Name
    LIFEGUARD MOUTH TO MASK RESUSCITATOR
    K Number
    K881086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Lifeguard Medical Products, Inc.
    Date Received
    March 14, 1988
    Decision Date
    April 14, 1988
    Product Code
    BTM
    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
    BTM Ventilator, Emergency, Manual (Resuscitator)

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    Other Clearances by Lifeguard Medical Products, Inc.

    K Number Device Name
    K013421 LIFEGUARD NASAL CPAP MASK AND ACCESSORIES
    K915296 MONOPOLAR ELECTRODE
    K920471 LEVY ARTICULATING RETRACTOR
    K915505 REGULATOR FLOWMETER
    K915297 TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM
    K915298 SUCTION/IRRIGATION CANNULA; CATLOG #532.00
    K880958 LIFEGUARD BACTERIAL AND VIRAL FILTER
    K880959 LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY
    K881087 LIFEGUARD SINGLE USE MANUAL RESUSCITATORS
    K863711 REGULATOR OXYGEN MECHANICAL
    Search all 12 clearances from Lifeguard Medical Products, Inc. →