WatchPAT400 (WP400)— 510(k) K250460

Substantially Equivalent

Itamar Medical , Ltd.

FDA 510(k) clearance K250460 for WatchPAT400 (WP400), Substantially Equivalent on 2025-09-05. Applicant: Itamar Medical , Ltd..

Clearance details

Applicant: Itamar Medical , Ltd.
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2025-02-18
Decision date: 2025-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

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