K242290 is an FDA 510(k) clearance for the DormoTech NLab. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Dormotech Medical, Ltd. (Afula, IL). The FDA issued a Cleared decision on January 8, 2025, 159 days after receiving the submission on August 2, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K242290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2024 |
| Decision Date | January 08, 2025 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MNR — Ventilatory Effort Recorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |