BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDISONO, LLC

    Reg #: 3010390468 · FEI: 3010390468 · Expires 2026
    View on FDA
    Products
    29
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    29

    Registration Details

    Registration Name
    MEDISONO, LLC
    Registration Number
    3010390468
    FEI Number
    3010390468
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3016 NW 82nd Ave
    City
    Doral
    State
    FL
    ZIP
    33122
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092970

    Owner / Operator

    Firm Name
    Medisono, LLC
    Operator Number
    10044902
    Address
    3016 NW 82nd Ave
    City
    Doral
    State
    FL
    Postal Code
    33122
    Country
    US
    Correspondent
    Monica Felitto

    Products

    Device Name Product Code
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Monitoring, Perinatal HGM
    Transducer, Ultrasonic, Obstetric HGL
    Oximeter DQA
    Gastroscope And Accessories, Flexible/Rigid FDS
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Colonoscope And Accessories, Flexible/Rigid FDF
    Flowmeter, Blood, Cardiovascular DPW
    Monitor, Ultrasonic, Fetal KNG
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, Breathing Frequency BZQ
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Detector And Alarm, Arrhythmia DSI
    Computer, Blood-Pressure DSK
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Monitor, St Segment With Alarm MLD
    Electrocardiograph DPS
    Continuous Measurement Thermometer FLL
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
    Colposcope (And Colpomicroscope) HEX
    Camera, Multi Format, Radiological LMC
    Computer, Diagnostic, Programmable DQK
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN

    Proprietary Names

    MM12 Patient Monitor MEDISONO Brand Mediblu, BLU12 Patient Monitor MEDISONO Brand Mediblu, MM1 Patient Monitor MEDISONO Ultrasound System FM02 Fetal Monitor MEDISONO Brand Mediblu MO1 Pulse Oximeter MEDISONO Brand Mediblu Video Endoscope System P11, P11 EXPERT, P12 Trolley, P12 Expert, P25 Trolley,P25 Expert Trolley Medisono Ultrasound System Central Patient Monitor System CMS4 MEDISONO Brand Mediblu FD1 Ultrasonic Pocket Doppler MEDISONO Brand Mediblu MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu MBV1 Vital Signs Monitor MEDISONO Brand Mediblu MM3 VITAL SIGNS MONITOR MEDISONO Brand Mediblu MS12 Digital Color Doppler Ultrasound System Medisono Ultrasound System MS55 Plus, P25 Expert, P12 Plus, P11 Plus, P9 Plus P3 Plus MEDISONO Ultrasound Diagnostic System Blood Pressure Holter System HA5P MEDISONO Brand Mediblu Video Colposcope DVC300 MEDISONO Brand Mediblu P1, P3, P10 Medisono Ultraspund System Sony UPD898MD UPX898MD Graphic Printers ECG MEDISONO Brand Mediblu ME3, ME6, ME12P, ME15P HA3P HOLTER SYSTEM MEDISONO Brand Mediblu BLU12+ Patient Monitor MEDISONO Brand Mediblu , BLU15+ Patient Monitor MEDISONO HP50P Blood Pressure Holter System MEDISONO Brand Mediblu S12/S12W PCG ECG MEDISONO Brand Mediblu MS22 PLUS Medisono Ultrasound System CART, EMERGENCY, CARDIOPULMONARY

    Establishment Types

    Repack or Relabel Medical Device