EndoPATx
FDA 510(k) K211557 · Itamar Medical , Ltd.
510(k) numberK211557
Submission
- Device name
- EndoPATx
- Applicant
- Itamar Medical , Ltd.
Caesarea, IL - Received
- May 19, 2021
- Decision date
- December 29, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
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More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254042 | WatchPAT SWMNR · Traditional | 07/31/2026SE |
| K250460 | WatchPAT400 (WP400)MNR · Traditional | 09/05/2025SE |
| K223675 | WatchPAT ONE (WP1)MNR · Special | 01/06/2023SE |
| K222331 | WatchPAT300 (WP300)MNR · Special | 09/14/2022SE |
| K203839 | WatchPAT200U (WP200U)MNR · Traditional | 03/21/2022SE |
| K183559 | WatchPAT ONEMNR · Traditional | 06/05/2019SE |
| K180775 | Watch-PAT300MNR · Traditional | 08/17/2018SE |
| K161579 | Watch-PAT200UMNR · Traditional | 02/24/2017SE |
| K153070 | Watch-PAT200UMNR · Traditional | 07/26/2016SE |
| K133859 | WATCH-PAT200U (WP200U)MNR · Traditional | 05/30/2014SE |
Questions and answers
When was EndoPATx cleared by the FDA?
EndoPATx (K211557) received a 510(k) decision of Substantially Equivalent on December 29, 2022, 589 days after the submission was received.
What is the product code of K211557?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.