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

    LIFEGUARD NASAL CPAP MASK AND ACCESSORIES

    K Number: K013421 · Decision Jan 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    12
    Review Days
    84

    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
    LIFEGUARD NASAL CPAP MASK AND ACCESSORIES
    K Number
    K013421
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lifeguard Medical Products, Inc.
    Date Received
    October 16, 2001
    Decision Date
    January 8, 2002
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

    Similar 510(k) Clearances

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

    Orion

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ResScan Essentials

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MySleepDash

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask

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

    Other Clearances by Lifeguard Medical Products, Inc.

    K Number Device Name
    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
    K881086 LIFEGUARD MOUTH TO MASK RESUSCITATOR
    K863711 REGULATOR OXYGEN MECHANICAL
    Search all 12 clearances from Lifeguard Medical Products, Inc. →