Data / Medical devices / Israel / Itamar Medical
Itamar Medical: FDA-registered device maker in CAESAREA Haifa, Israel, 11 510(k) clearances
Itamar Medical is registered with the FDA (registration 3003616071) in CAESAREA Haifa, Israel. It lists 4 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 5, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003616071
- Address
- 9 Halamish ST., CAESAREA Haifa, Israel, 3088900
- Owner or operator
- ITAMAR MEDICAL INC (9041901)
- Roles
- Manufacturer
- First device listed
- January 16, 2008
- Registered through
- 2026
- Brand names listed
- Central+ sensor, CentralPlus sensor, CloudPAT, EPx, Endo PAT 2000, EndoPATx, Pneumatic Endo probes, RESBP sensor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 5, 2025 | K250460 | WatchPAT400 (WP400) | MNR | Substantially Equivalent | Itamar Medical , Ltd. | accessdata.fda.gov |
| January 6, 2023 | K223675 | WatchPAT ONE (WP1) | MNR | Substantially Equivalent | Itamar Medical , Ltd. | accessdata.fda.gov |
| December 29, 2022 | K211557 | EndoPATx | DQK | Substantially Equivalent | Itamar Medical , Ltd. | accessdata.fda.gov |
| September 14, 2022 | K222331 | WatchPAT300 (WP300) | MNR | Substantially Equivalent | Itamar Medical , Ltd. | accessdata.fda.gov |
| March 21, 2022 | K203839 | WatchPAT200U (WP200U) | MNR | Substantially Equivalent | Itamar Medical , Ltd. | accessdata.fda.gov |
| June 5, 2019 | K183559 | WatchPAT ONE | MNR | Substantially Equivalent | Itamar Medical , Ltd. | accessdata.fda.gov |
| August 17, 2018 | K180775 | Watch-PAT300 | MNR | Substantially Equivalent | Itamar Medical , Ltd. | accessdata.fda.gov |
| February 24, 2017 | K161579 | Watch-PAT200U | MNR | Substantially Equivalent | Itamar Medical , Ltd. | accessdata.fda.gov |
| July 26, 2016 | K153070 | Watch-PAT200U | MNR | Substantially Equivalent | Itamar Medical , Ltd. | accessdata.fda.gov |
| May 30, 2014 | K133859 | WATCH-PAT200U (WP200U) | MNR | Substantially Equivalent | Itamar Medical , Ltd. | accessdata.fda.gov |
| November 12, 2003 | K032519 | ENDO PAT 2000 | DQK | Substantially Equivalent | Itamar Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilatory Effort Recorder
- All makers of Powered Laser Surgical Instrument
- All makers of Computer, Diagnostic, Programmable
- All makers of Medical Device Data System
Updated September 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.