Medisono, LLC
Doral, FL, US
MEDISONO, LLC appears in FDA device records in Doral, FL. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Medisono, LLC between 2017 and 2024. The busiest year on record is 2017, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231659 | MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus) | IYN | Substantially Equivalent | |
| K170078 | Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley | IYN | Substantially Equivalent | |
| K163688 | Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 | IYN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010390468 | 3010390468 | MEDISONO, LLC | 3016 NW 82nd Ave, Doral, FL 33122 US | 2026 | and 19 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- LMCCamera, Multi Format, Radiological
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- FDFColonoscope And Accessories, Flexible/Rigid
- HEXColposcope (And Colpomicroscope)
- DSKComputer, Blood-Pressure
- DQKComputer, Diagnostic, Programmable
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- MWJElectrocardiograph, Ambulatory (Without Analysis)
- MLOElectrocardiograph, Ambulatory, With Analysis Algorithm
- NWBEndoscope, Accessories, Narrow Band Spectrum
- DPWFlowmeter, Blood, Cardiovascular
- FDSGastroscope And Accessories, Flexible/Rigid
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLDMonitor, St Segment With Alarm
- KNGMonitor, Ultrasonic, Fetal
- DQAOximeter
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
- ITXTransducer, Ultrasonic, Diagnostic
- HGLTransducer, Ultrasonic, Obstetric
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain