K250460
- 510(k) number
- K250460
- Device name
- WatchPAT400 (WP400)
- Applicant
- Itamar Medical , Ltd. IL
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2025-09-05
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250460.pdf
Official FDA record: K250460
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.