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

    FLEXICAIR EXLIPSE

    K Number: K951001 · Decision Jun 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    56
    Applicant Total
    33
    Review Days
    116

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    Basic Information

    Device Name
    FLEXICAIR EXLIPSE
    K Number
    K951001
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5170
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hill-Rom, Inc.
    Date Received
    March 3, 1995
    Decision Date
    June 27, 1995
    Product Code
    IOQ
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IOQ Bed, Flotation Therapy, Powered

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    Other Clearances by Hill-Rom, Inc.

    K Number Device Name
    K202018 Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
    K180079 Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
    K013709 HILL-ROM PRIMAVIEW MONITOR SYSTEM
    K973705 CONTOR TABLE SURFACE
    K981081 BRIGHTSTAR
    K972111 RUMORS DYNAMIC AIR THERAPY UNIT
    K971366 INCUWARMER
    K970636 TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
    K964873 SILKAIR LOW AIRLOSS THERAPY
    K964223 CLINITRON RITE-HITE
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