SOZO Body Fluid Analyzer
FDA 510(k) K193410 · ImpediMed Limited
510(k) numberK193410
Submission
- Device name
- SOZO Body Fluid Analyzer
- Applicant
- ImpediMed Limited
Pinkenba, AU - Received
- December 9, 2019
- Decision date
- October 2, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSB – Plethysmograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
Other 510(k)s with product code DSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional | ImpediMed Limited | 08/17/2026SE |
| K250634 | BCM2-Body Composition MonitorDSB · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 11/24/2025SE |
| K243727 | Re:BalansDSB · Traditional | Mode Sensors AS | 10/16/2025SE |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001DSB · Traditional | Cardioset Medical , Ltd. | 09/09/2025SE |
| K232089 | SOZO ProDSB · Traditional | ImpediMed Limited | 10/17/2023SE |
| K223217 | Zynex Monitoring System, Model CM-1600DSB · Traditional | Zynex Medical, Inc. | 06/16/2023SE |
| K211585 | Bodyport Cardiac ScaleDSB · Traditional | Bodyport, Inc. | 07/29/2022SE |
| K203473 | SozoDSB · Traditional | ImpediMed Limited | 04/19/2021SE |
| K191697 | Cardiac Monitor 1500DSB · Traditional | Zynex Medical, Inc. | 02/21/2020SE |
| K180479 | ReDS SystemDSB · Traditional | Sensible Medical Innovations , Ltd. | 02/28/2019SE |
More from Sensible Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional | 08/17/2026SE |
| K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)OBH · Traditional | 01/28/2026SE |
| K232089 | SOZO ProDSB · Traditional | 10/17/2023SE |
| K230531 | SOZO ProQJB · Special | 05/04/2023SE |
| K230530 | SOZO ProOBH · Special | 05/04/2023SE |
| K203473 | SozoDSB · Traditional | 04/19/2021SE |
| K190529 | SozoQJB · Traditional | 11/25/2019SE |
| K180126 | SozoOBH · Traditional | 04/16/2018SE |
| K172507 | SozoDSB · Traditional | 12/22/2017SE |
| K172122 | SozoOBH · Special | 08/11/2017SE |
Questions and answers
When was SOZO Body Fluid Analyzer cleared by the FDA?
SOZO Body Fluid Analyzer (K193410) received a 510(k) decision of Substantially Equivalent on October 2, 2020, 298 days after the submission was received.
What is the product code of K193410?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.