510(k) K250135
K250135 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp/ Excel Medical for the device "WAVE Clinical Platform (2.0.000)". The FDA issued a decision of Substantially Equivalent on January 16, 2026. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2026
- Date Received
- January 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type