WatchPAT200U (WP200U)
FDA 510(k) K203839 · Itamar Medical , Ltd.
510(k) numberK203839
Submission
- Device name
- WatchPAT200U (WP200U)
- Applicant
- Itamar Medical , Ltd.
Caesarea, IL - Received
- December 30, 2020
- Decision date
- March 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNR – Ventilatory Effort Recorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
Other 510(k)s with product code MNR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254042 | WatchPAT SWMNR · Traditional | Itamar Medical , Ltd. | 07/31/2026SE |
| K260050 | WRAP SystemMNR · Traditional | Huneo, LLC | 07/15/2026SE |
| K253148 | RX-1 SleepMNR · Traditional | Vivaquant, Inc. Dba Rhythm Express | 06/22/2026SE |
| K252628 | CassieMNR · Traditional | Wesper, Inc. | 04/27/2026SE |
| K252497 | Sansa HsatMNR · Traditional | Huxley Medical | 12/10/2025SE |
| K250882 | Sansa HsatMNR · Traditional | Huxley Medical | 10/29/2025SE |
| K250460 | WatchPAT400 (WP400)MNR · Traditional | Itamar Medical , Ltd. | 09/05/2025SE |
| K252383 | Somfit DMNR · Special | Compumedics Limited | 08/28/2025SE |
| K243220 | Onera STS 2 (ONERA STS 2)MNR · Traditional | Onera B.V. | 07/03/2025SE |
| K242224 | Happy Health Home Sleep TestMNR · Traditional | Happy Health, Inc. | 06/18/2025SE |
More from Happy Health, 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 |
| K211557 | EndoPATxDQK · Traditional | 12/29/2022SE |
| K222331 | WatchPAT300 (WP300)MNR · Special | 09/14/2022SE |
| 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 WatchPAT200U (WP200U) cleared by the FDA?
WatchPAT200U (WP200U) (K203839) received a 510(k) decision of Substantially Equivalent on March 21, 2022, 446 days after the submission was received.
What is the product code of K203839?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.