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

    LIFECARE PRESSURE ALARM CAT. NO. 34-010

    K Number: K894361 · Decision Oct 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    77
    Applicant Total
    20
    Review Days
    83

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    Basic Information

    Device Name
    LIFECARE PRESSURE ALARM CAT. NO. 34-010
    K Number
    K894361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2600
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Lifecare Services, Inc.
    Date Received
    July 14, 1989
    Decision Date
    October 5, 1989
    Product Code
    CAP
    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
    CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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    Other Clearances by Lifecare Services, Inc.

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    K894779 LIFECARE NASAL MASK KIT CAT. NO. 06-800
    K895592 FREEWAY NEBULIZER COMPRESSOR
    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. →