The following data is part of a premarket notification filed by Impedimed Limited with the FDA for Sozo Body Fluid Analyzer.
| Device ID | K193410 |
| 510k Number | K193410 |
| Device Name: | SOZO Body Fluid Analyzer |
| Classification | Plethysmograph, Impedance |
| Applicant | ImpediMed Limited Unit 1, 50 Parker Court Pinkenba, AU 4008 |
| Contact | Catherine Kingsford |
| Correspondent | Reuben Lawson ImpediMed Inc. 5900 Pasteur Court, Unit 125 Carlsbad, CA 92008 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-09 |
| Decision Date | 2020-10-02 |