510(k) K260224
K260224 is an FDA 510(k) premarket notification submitted by ImpediMed Limited for the device "MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)". The FDA issued a decision of Substantially Equivalent on August 17, 2026. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. ImpediMed Limited has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2026
- Date Received
- January 26, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type