510(k) clearance
MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
- 510(k) number
- K260224
- Applicant
- ImpediMed Limited
- Decision date
- Aug 17, 2026
- Date received
- Jan 26, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DSB
- Device type
- Plethysmograph, Impedance
- Device class
- Class II
- Regulation
- 21 CFR 870.2770
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Lindfield, AU