FDA.reportPublic FDA data

ITAMAR MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036160713003616071ITAMAR MEDICAL1N2026-01-019 Halamish ST. CAESAREA Haifa IL 3088900

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
192441383688663K250460WatchPAT400 (WP400)MNR2025-09-05
192441113459785K223675WatchPAT ONE (WP1)MNR2023-01-06
192441082769509K222331WatchPAT300 (WP300)MNR2022-09-14
192441749868446K211557EndoPATxDQK2022-12-29
192442054879799K203839WatchPAT200U (WP200U)MNR2022-03-21
192441732605764K183559WatchPAT ONEMNR2019-06-05
192441443737662K180775Watch-PAT300MNR2018-08-17
192441732772222K161579Watch-PAT200UMNR2017-02-24
192441551030404K153070Watch-PAT200UMNR2016-07-26
192442067005537K133859WATCH-PAT200U (WP200U)MNR2014-05-30
192441476034879K102567WATCH-PAT 200S-3 (WP200S-3)MNR2011-06-02
192441340112852K081982WATCH-PAT 200S-2 (WP200S-2)MNR2008-08-14
192441224405970K081037WATCH-PAT 200I (WP200I)MNR2008-06-09
192441371944803K032519ENDO PAT 2000DQK2003-11-12
192441657768764

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MNR122025-09-05
DQK22022-12-29

PMN#