K252628
- 510(k) number
- K252628
- Device name
- CASSIE
- Applicant
- Wesper, Inc. NY · US
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2026-04-27
- Date received
- 2025-08-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K252628.pdf
Official FDA record: K252628
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.