Cleared Traditional

WatchPAT200U (WP200U)

K203839 · Itamar Medical , Ltd. · Anesthesiology
Mar 2022
Decision
446d
Days
Class 2
Risk

About This 510(k) Submission

K203839 is an FDA 510(k) clearance for the WatchPAT200U (WP200U), 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 March 21, 2022, 446 days after receiving the submission on December 30, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K203839 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2020
Decision Date March 21, 2022
Days to Decision 446 days
Submission Type Traditional
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