BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIBEL HEALTH INC.

    Reg #: 3015529350 · FEI: 3015529350 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    13

    Registration Details

    Registration Name
    SIBEL HEALTH INC.
    Registration Number
    3015529350
    FEI Number
    3015529350
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2017 N Mendell Street, Suite 2SE
    City
    Chicago
    State
    IL
    ZIP
    60614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K253021

    Owner / Operator

    Firm Name
    Sibel Health Inc.
    Operator Number
    10060887
    Address
    2017 N Mendell St, Suite 2SE
    City
    Chicago
    State
    IL
    Postal Code
    60614
    Country
    US
    Correspondent
    Kevin Dwyer

    Products

    Device Name Product Code
    System, Monitoring, Perinatal HGM
    Alarm, Blood-Pressure DSJ
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Monitor, Bed Patient KMI
    System, Test, Thyroglobulin MSW
    System, Network And Communication, Physiological Monitors MSX
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Ventilatory Effort Recorder MNR
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Continuous Measurement Thermometer FLL
    Oximeter DQA
    Monitor, Breathing Frequency BZQ
    Medical Device Data System OUG

    Proprietary Names

    ANNE Maternal Software Platform ANNE Maternal ANNE Sleep ANNE One ANNE Chest ANNE Limb ANNE Pediatric

    Establishment Types

    Manufacture Medical Device