K201495 is an FDA 510(k) clearance for the Maxxi Flow Sensor. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Neurovirtual USA, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on December 14, 2020, 192 days after receiving the submission on June 5, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K201495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2020 |
| Decision Date | December 14, 2020 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| 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 |