ClearanceBrief
Company ยท IL

Itamar Medical , Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.

17510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
MNRVentilatory Effort Recorder15
DQKComputer, Diagnostic, Programmable2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 31, 2026K254042WatchPAT SW
Itamar Medical , Ltd., IL
MNR
Sep 5, 2025K250460WatchPAT400 (WP400)
Itamar Medical , Ltd., IL
MNR
Jan 6, 2023K223675WatchPAT ONE (WP1)
Itamar Medical , Ltd., IL
MNR
Dec 29, 2022K211557EndoPATx
Itamar Medical , Ltd., IL
DQK
Sep 14, 2022K222331WatchPAT300 (WP300)
Itamar Medical , Ltd., IL
MNR
Mar 21, 2022K203839WatchPAT200U (WP200U)
Itamar Medical , Ltd., IL
MNR
Jun 5, 2019K183559WatchPAT ONE
Itamar Medical , Ltd., IL
MNR
Aug 17, 2018K180775Watch-PAT300
Itamar Medical , Ltd., IL
MNR
Feb 24, 2017K161579Watch-PAT200U
Itamar Medical , Ltd., IL
MNR
Jul 26, 2016K153070Watch-PAT200U
Itamar Medical , Ltd., IL
MNR
May 30, 2014K133859WATCH-PAT200U (WP200U)
Itamar Medical , Ltd.
MNR
Jun 2, 2011K102567WATCH-PAT 200S-3 (WP200S-3)
Itamar Medical , Ltd.
MNR
Aug 14, 2008K081982WATCH-PAT 200S-2 (WP200S-2)
Itamar Medical
MNR
Jun 9, 2008K081037WATCH-PAT 200I (WP200I)
Itamar Medical
MNR
May 23, 2008K080427WATCH-PAT MODEL 100S-2
Itamar Medical
MNR
Dec 29, 2004K042916WATCH PAT 100S
Itamar Medical
MNR
Nov 12, 2003K032519ENDO PAT 2000
Itamar Medical, IL
DQK

Latest recalls

DateFirm and productCodeLinked 510(k)
No recalls in this window.
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