Cleared Traditional

WatchPAT ONE

K183559 · Itamar Medical , Ltd. · Anesthesiology
Jun 2019
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K183559 is an FDA 510(k) clearance for the WatchPAT ONE, 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 June 5, 2019, 167 days after receiving the submission on December 20, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K183559 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2018
Decision Date June 05, 2019
Days to Decision 167 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