K213463 is an FDA 510(k) clearance for the NightOwl. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Ectosense NV (Rotselaar, BE). The FDA issued a Cleared decision on December 16, 2021, 50 days after receiving the submission on October 27, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K213463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2021 |
| Decision Date | December 16, 2021 |
| Days to Decision | 50 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNR - Ventilatory Effort Recorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |