Medical Device Manufacturer · US , Washington , DC

Itamar Medical , Ltd. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2011

Recent clearances: WatchPAT400 (WP400), WatchPAT ONE (WP1), EndoPATx

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Itamar Medical , Ltd. Anesthesiology ✕

10 devices

1-10 of 10

Cleared Sep 05, 2025

WatchPAT400 (WP400)

Anesthesiology · 199d

Cleared Jan 06, 2023

WatchPAT ONE (WP1)

Anesthesiology · 30d

Cleared Sep 14, 2022

WatchPAT300 (WP300)

Anesthesiology · 43d

Cleared CT Mar 21, 2022

WatchPAT200U (WP200U)

Anesthesiology · 446d

Cleared Jun 05, 2019

Anesthesiology · 167d

Cleared Aug 17, 2018

Anesthesiology · 147d

Cleared Feb 24, 2017

Anesthesiology · 262d

Cleared Jul 26, 2016

Anesthesiology · 278d

Cleared May 30, 2014

WATCH-PAT200U (WP200U)

Anesthesiology · 162d

Cleared Jun 02, 2011

WATCH-PAT 200S-3 (WP200S-3)

Anesthesiology · 268d

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Apr 27, 2026