K252383 is an FDA 510(k) clearance for the Somfit D. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Compumedics Limited (Abbotsford, AU). The FDA issued a Cleared decision on August 28, 2025, 28 days after receiving the submission on July 31, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K252383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2025 |
| Decision Date | August 28, 2025 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |