DormoTech NLab
FDA 510(k) K242290 · Dormotech Medical, Ltd.
510(k) numberK242290
Submission
- Device name
- DormoTech NLab
- Applicant
- Dormotech Medical, Ltd.
Afula, IL - Received
- August 2, 2024
- Decision date
- January 8, 2025
- 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 |
|---|---|---|
| K230148 | VlabGWL · Traditional | 10/11/2023SE |
Questions and answers
When was DormoTech NLab cleared by the FDA?
DormoTech NLab (K242290) received a 510(k) decision of Substantially Equivalent on January 8, 2025, 159 days after the submission was received.
What is the product code of K242290?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.