WatchPAT SW— 510(k) K254042
Substantially EquivalentItamar Medical , Ltd.
FDA 510(k) clearance K254042 for WatchPAT SW, Substantially Equivalent on 2026-07-31. Applicant: Itamar Medical , Ltd.. Device class: 2.
Summary
WatchPAT SW from Itamar Medical is filed under MNR, ventilatory effort recorders. The record doesn't expand "SW" or describe what the product records.
Class II, 21 CFR 868.2375. Anesthesiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Itamar Medical filed from Caesarea, Israel. Review took 227 calendar days (December 16, 2025 to July 31, 2026).
Clearance details
- Applicant
- Itamar Medical , Ltd.
- Product code
- Product code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Caesarea, IL
Recent devices under product code MNR
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