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Itamar Medical , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250460WatchPAT400 (WP400)September 5, 2025
K223675WatchPAT ONE (WP1)January 6, 2023
K211557EndoPATxDecember 29, 2022
K222331WatchPAT300 (WP300)September 14, 2022
K203839WatchPAT200U (WP200U)March 21, 2022
K183559WatchPAT ONEJune 5, 2019
K180775Watch-PAT300August 17, 2018
K161579Watch-PAT200UFebruary 24, 2017
K153070Watch-PAT200UJuly 26, 2016
K133859WATCH-PAT200U (WP200U)May 30, 2014
K102567WATCH-PAT 200S-3 (WP200S-3)June 2, 2011
K081982WATCH-PAT 200S-2 (WP200S-2)August 14, 2008
K081037WATCH-PAT 200I (WP200I)June 9, 2008
K080427WATCH-PAT MODEL 100S-2May 23, 2008
K042916WATCH PAT 100SDecember 29, 2004
K032519ENDO PAT 2000November 12, 2003