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

    STABILET

    K Number: K942904 · Decision Sep 16, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    91
    Applicant Total
    33
    Review Days
    87

    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
    STABILET
    K Number
    K942904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5130
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hill-Rom, Inc.
    Date Received
    June 21, 1994
    Decision Date
    September 16, 1994
    Product Code
    FMT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMT Warmer, Infant Radiant

    Similar 510(k) Clearances

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

    Babyroo TN300

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Babyroo TN300

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Giraffe Omnibed Carestation CS1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Panda iRes Warmer, Giraffe Warmer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Hydro-Temp Neonatal Skin Temperature Probe Cover

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    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
    Search all 33 clearances from Hill-Rom, Inc. →