K250135
- 510(k) number
- K250135
- Device name
- WAVE Clinical Platform (2.0.000)
- Applicant
- Baxter Healthcare Corp/ Excel Medical FL · US
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2026-01-16
- Date received
- 2025-01-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250135.pdf
Official FDA record: K250135
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.