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 |