K122516 is an FDA 510(k) clearance for the EMBLETTA MPR. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Embla Systems (Kanata, CA). The FDA issued a Cleared decision on February 21, 2013, 188 days after receiving the submission on August 17, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K122516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2012 |
| Decision Date | February 21, 2013 |
| Days to Decision | 188 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 |