K111742 is an FDA 510(k) clearance for the MDRIVE. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Embla Systems (Thornton, US). The FDA issued a Cleared decision on August 31, 2011, 71 days after receiving the submission on June 21, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K111742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2011 |
| Decision Date | August 31, 2011 |
| Days to Decision | 71 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 |