MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)— 510(k) K260224
Substantially EquivalentImpediMed Limited
FDA 510(k) clearance K260224 for MySOZO Software version 6.1.0.1 (SW version 6.1.0.1), Substantially Equivalent on 2026-08-17. Applicant: ImpediMed Limited. Device class: 2.
Summary
ImpediMed's MySOZO Software, version 6.1.0.1, is filed under product code DSB, impedance plethysmographs. The record doesn't describe the software beyond its name and that code.
Class II, 21 CFR 870.2770. The Gastroenterology and Urology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
ImpediMed filed from Lindfield, Australia. The decision came 203 calendar days after receipt (January 26 to August 17, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- ImpediMed Limited
- Product code
- Product code DSB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lindfield, AU
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