Cleared Special

WatchPAT300 (WP300)

K222331 · Itamar Medical , Ltd. · Anesthesiology
Sep 2022
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K222331 is an FDA 510(k) clearance for the WatchPAT300 (WP300), a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Itamar Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on September 14, 2022, 43 days after receiving the submission on August 2, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K222331 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2022
Decision Date September 14, 2022
Days to Decision 43 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375