Itamar Medical
CAESAREA Haifa, IL
ITAMAR MEDICAL appears in FDA device records in CAESAREA Haifa, IL. FDA records list 17 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Itamar Medical between 2003 and 2026. The busiest year on record is 2008, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 1 |
| 2008 | 3 |
| 2011 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 3 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254042 | WatchPAT SW | MNR | Substantially Equivalent | |
| K250460 | WatchPAT400 (WP400) | MNR | Substantially Equivalent | |
| K223675 | WatchPAT ONE (WP1) | MNR | Substantially Equivalent | |
| K211557 | EndoPATx | DQK | Substantially Equivalent | |
| K222331 | WatchPAT300 (WP300) | MNR | Substantially Equivalent | |
| K203839 | WatchPAT200U (WP200U) | MNR | Substantially Equivalent | |
| K183559 | WatchPAT ONE | MNR | Substantially Equivalent | |
| K180775 | Watch-PAT300 | MNR | Substantially Equivalent | |
| K161579 | Watch-PAT200U | MNR | Substantially Equivalent | |
| K153070 | Watch-PAT200U | MNR | Substantially Equivalent | |
| K133859 | WATCH-PAT200U (WP200U) | MNR | Substantially Equivalent | |
| K102567 | WATCH-PAT 200S-3 (WP200S-3) | MNR | Substantially Equivalent | |
| K081982 | WATCH-PAT 200S-2 (WP200S-2) | MNR | Substantially Equivalent | |
| K081037 | WATCH-PAT 200I (WP200I) | MNR | Substantially Equivalent | |
| K080427 | WATCH-PAT MODEL 100S-2 | MNR | Substantially Equivalent | |
| K042916 | WATCH PAT 100S | MNR | Substantially Equivalent | |
| K032519 | ENDO PAT 2000 | DQK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003616071 | 3003616071 | ITAMAR MEDICAL | 9 Halamish ST., CAESAREA Haifa 3088900 IL | 2026 | |
| 3004719741 | 3004719741 | ITAMAR MEDICAL INC. | 3290 Cumberland Club Dr Ste 100, Atlanta, GA 30339 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain