510(k) K243727
K243727 is an FDA 510(k) premarket notification submitted by Mode Sensors AS for the device "Re:Balans". The FDA issued a decision of Substantially Equivalent on October 16, 2025. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2025
- Date Received
- December 3, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type