zoll.comWatchPAT400 (WP400)
Itamar Medical , Ltd.
ITAMAR MEDICAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003616071 | 3003616071 | ITAMAR MEDICAL | 1 | N | 2026-01-01 | 9 Halamish ST. CAESAREA Haifa IL 3088900 |
| 3004719741 | 3004719741 | ITAMAR MEDICAL INC. | 1 | Y | 2026-01-01 | 3290 Cumberland Club Dr Ste 100 Atlanta GA US 30339 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07290109222035 | Central Plus Sensor for Watch-PAT200U - Central Plus Sensor for WatchPAT products | 1-888-748-2627 | itamar-support@zoll.com |
| 07290109222059 | RESBP for Watch-PAT200U - RESBP Sensor, Replacement - ROW | 1-888-748-2627 | itamar-support@zoll.com |
| 07290109222073 | Central Plus Sensor for Watch-PAT200U - Central Plus Sensor, Replacement - Euro | 1-888-748-2627 | itamar-support@zoll.com |
| 07290109222080 | Central Plus Sensor for Watch-PAT200U - Central Plus Sensor, Replacement - US | 1-888-748-2627 | itamar-support@zoll.com |
| 07290109222097 | Central Plus Sensor for Watch-PAT200U - Central Plus Sensor, Replacement - Euro | 1-888-748-2627 | itamar-support@zoll.com |
| 07290109222813 | 12 Adhesive Foam Disk 2side For Itamar SBP - 12 Adhesive Foam Disk 2side For Itamar SBP/RESBP | 1-888-748-2627 | itamar-support@zoll.com |
| 07290109222837 | Tamper-Proof Bracelets (24), WatchPAT | 1-888-748-2627 | itamar-support@zoll.com |
| 07290109223568 | WatchPAT400 - WatchPAT400 Device | 1-888-748-2627 | itamar-support@zoll.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 19244 | 1383688663 | K250460 | WatchPAT400 (WP400) | MNR | 2025-09-05 |
| 19244 | 1113459785 | K223675 | WatchPAT ONE (WP1) | MNR | 2023-01-06 |
| 19244 | 1082769509 | K222331 | WatchPAT300 (WP300) | MNR | 2022-09-14 |
| 19244 | 1749868446 | K211557 | EndoPATx | DQK | 2022-12-29 |
| 19244 | 2054879799 | K203839 | WatchPAT200U (WP200U) | MNR | 2022-03-21 |
| 19244 | 1732605764 | K183559 | WatchPAT ONE | MNR | 2019-06-05 |
| 19244 | 1443737662 | K180775 | Watch-PAT300 | MNR | 2018-08-17 |
| 19244 | 1732772222 | K161579 | Watch-PAT200U | MNR | 2017-02-24 |
| 19244 | 1551030404 | K153070 | Watch-PAT200U | MNR | 2016-07-26 |
| 19244 | 2067005537 | K133859 | WATCH-PAT200U (WP200U) | MNR | 2014-05-30 |
| 19244 | 1476034879 | K102567 | WATCH-PAT 200S-3 (WP200S-3) | MNR | 2011-06-02 |
| 19244 | 1340112852 | K081982 | WATCH-PAT 200S-2 (WP200S-2) | MNR | 2008-08-14 |
| 19244 | 1224405970 | K081037 | WATCH-PAT 200I (WP200I) | MNR | 2008-06-09 |
| 19244 | 1371944803 | K032519 | ENDO PAT 2000 | DQK | 2003-11-12 |
| 19244 | 1657768764 |
Product Codes Associated With Registrations#
PMN#
WatchPAT ONE (WP1)
Itamar Medical , Ltd.
EndoPATx
Itamar Medical , Ltd.
WatchPAT300 (WP300)
Itamar Medical, Ltd
WatchPAT200U (WP200U)
Itamar Medical , Ltd.
WatchPAT ONE
Itamar Medical, Ltd.
Watch-PAT300
Itamar Medical, Ltd.
Watch-PAT200U
ITAMAR MEDICAL, LTD.
Watch-PAT200U
ITAMAR MEDICAL, LTD.
WATCH-PAT200U (WP200U)
ITAMAR MEDICAL LTD
WATCH-PAT 200S-3 (WP200S-3)
ITAMAR MEDICAL LTD
WATCH-PAT 200S-2 (WP200S-2)
ITAMAR MEDICAL
WATCH-PAT 200I (WP200I)
ITAMAR MEDICAL
WATCH-PAT MODEL 100S-2
ITAMAR MEDICAL
WATCH PAT 100S
ITAMAR MEDICAL
ENDO PAT 2000
ITAMAR MEDICAL
SLEEP PAT 200 DEVICE
ITAMAR MEDICAL (C.M.) 1997 LTD.
WATCH-PAT 100
ITAMAR MEDICAL (C.M.) 1997 LTD.
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
ITAMAR MEDICAL (C.M.) 1997 LTD.
GUDID#
Tamper-Proof Bracelets (24), WatchPAT
2016-09-06
12 Adhesive Foam Disk 2side For Itamar SBP - 12 Adhesive Foam Disk 2side For Itamar SBP/RESBP
2016-09-07
Central Plus Sensor for Watch-PAT200U - Central Plus Sensor, Replacement - Euro
2018-06-14
Central Plus Sensor for Watch-PAT200U - Central Plus Sensor, Replacement - US
2018-06-14
Central Plus Sensor for Watch-PAT200U - Central Plus Sensor, Replacement - Euro
2018-05-23
RESBP for Watch-PAT200U - RESBP Sensor, Replacement - ROW
2017-05-15
Central Plus Sensor for Watch-PAT200U - Central Plus Sensor for WatchPAT products
2017-05-15
WatchPAT400 - WatchPAT400 Device
2025-12-01
Watch-PAT200U - Watch-PAT200U Device (EU)
2018-05-23
Itamar Snoring + BP for Watch-PAT 200S-3 and Watch-PAT200U - Itamar Snoring + BP For WatchPAT,KIT
2016-09-06
Watch-PAT200U - Watch-PAT200U Device
2017-08-09
Watch-PAT200U - Watch-PAT200U Device
2017-08-09
Watch-PAT200U - Watch-PAT200U Device
2017-08-09
Watch-PAT200U - Watch-PAT200U Device (EU)
2018-05-23
Watch-PAT200U - Watch-PAT200U Device
2017-08-09
Central Plus Sensor - Central Plus Sensor for WatchPAT devices
2023-03-13
WatchPAT400 - WatchPAT400 Device
2025-12-01
Endo PAT 2000 - Endo PAT 2000 Device
2016-09-05
Endo PAT 2000 - EndoPAT2000 Device
2016-09-05
Accessories for Endo PAT 2000 - Accessories, EndoPAT2000
2016-09-06
Watch-PAT300 - Watch-PAT300 Device
2019-03-27
WatchPAT ONE-M
2021-03-18
12 WatchPAT ONE-M Probes
2021-03-18
WatchPAT ONE - WatchPAT ONE for Canada
2023-03-13
WatchPAT ONE - WatchPAT ONE E for Canada
2023-03-13
EndoPATx - EndoPATx Device
2023-04-27
Accessories, EndoPATx - Accessories for EndoPATx
2023-04-27
Endo PAT 2000 - Endo PAT 2000 Device
2017-12-31
Endo PAT 2000 - EndoPAT2000 Device
2017-12-31
WatchPAT ONE - WatchPAT ONE-M for Canada
2023-03-13
WatchPAT ONE - WatchPAT ONE E
2020-05-12
Watch-PAT300 - Watch-PAT300 Device
2019-08-20
Watch-PAT300 - Watch-PAT300 Device
2019-06-30
Anchors(30) for Endo PAT 2000 - Anchors(30), EndoPAT
2016-09-06
12 Pneumatic Endo probes for Endo PAT 2000 - 12 Pneumatic Endo probes
2016-09-05
WatchPATONE - WatchPAT ONE
2019-06-30
12 uPAT Probes for Watch-PAT - 12 uPAT Probes
2019-06-18
EndoPATx - EndoPATx Device
2023-04-27
Watch-PAT 200i - Watch-PAT200 Device
2017-08-09
Watch-PAT 200i - Watch-PAT200 Device
2016-11-20