K254042
- 510(k) number
- K254042
- Device name
- WatchPAT SW
- Applicant
- Itamar Medical , Ltd. IL
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2026-07-31
- Date received
- 2025-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K254042.pdf
Official FDA record: K254042
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.