510(k) K190529
- Device
- SOZO
- Applicant
- ImpediMed Limited
- 510(k) number
- K190529
- Product code
- DSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-11-25
- Date received
- 2019-03-04
- Regulation
- 870.2770
- Classification name
- Plethysmograph, Impedance
- Medical specialty
- Cardiovascular
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Catherine Kingsford
- Address
- Unit 1, 50 Parker Ct. Pinkenba AU 4008 4008
FDA Registration Numbers#
- 3004782476
- 3003695829
- 3005699942
Source Documents#
Other 510(k) Records For Product Code DSB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250634 | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-24 |
| K243727 | Re:Balans | Mode Sensors AS | 2025-10-16 |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical , Ltd. | 2025-09-09 |
| K232089 | SOZO Pro | ImpediMed Limited | 2023-10-17 |
| K223217 | Zynex Monitoring System, Model CM-1600 | Zynex Medical, Inc. | 2023-06-16 |
| K211585 | Bodyport Cardiac Scale | Bodyport, Inc. | 2022-07-29 |
| K203473 | SOZO | ImpediMed Limited | 2021-04-19 |
| K193410 | SOZO Body Fluid Analyzer | ImpediMed Limited | 2020-10-02 |
| K191697 | Cardiac Monitor 1500 | Zynex Medical, Inc. | 2020-02-21 |
| K180479 | ReDS System | Sensible Medical Innovations , Ltd. | 2019-02-28 |
| K172431 | Cardiovascular Analzyer | Physiowave, Inc. | 2018-03-14 |
| K172507 | SOZO | ImpediMed Limited | 2017-12-22 |
| K172196 | ECOM™ Cardiac Output Monitoring System | Ecom Medical, Inc. | 2017-09-19 |
| K150095 | ReDs Wearable System | Sensible Medical Innovations , Ltd. | 2015-08-06 |
| K142503 | IMED-Z FLUID STATUS MONITOR | Intersection Medical, Inc. | 2015-06-05 |
Legacy Summary#
summary
FDA Review#
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