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

    LIFECARE CPAP-100

    K Number: K912224 · Decision Sep 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    20
    Review Days
    126

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    Basic Information

    Device Name
    LIFECARE CPAP-100
    K Number
    K912224
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lifecare Services, Inc.
    Date Received
    May 20, 1991
    Decision Date
    September 23, 1991
    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)

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    Other Clearances by Lifecare Services, Inc.

    K Number Device Name
    K913423 LIFECARE REMOTE ALARM II
    K910947 NEV-10 NEGATIVE PRESSURE VENTILATOR
    K894779 LIFECARE NASAL MASK KIT CAT. NO. 06-800
    K895592 FREEWAY NEBULIZER COMPRESSOR
    K894361 LIFECARE PRESSURE ALARM CAT. NO. 34-010
    K880378 LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001
    K873570 LIFECARE EXHALATION VALVE #06-699
    K862212 LIFECARE REMOTE ALARM #34-001
    K842876 PORTABLE LIFECARE VENTILATOR PLV-102
    K832467 PORTABLE LIFECARE VENTILATOR PLV-100
    Search all 20 clearances from Lifecare Services, Inc. →