Submission Details
| 510(k) Number | K140049 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 09, 2014 |
| Decision Date | May 29, 2014 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
K140049 is an FDA 510(k) clearance for the MOVES SLC, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Thornhill Research, Inc. (Toronto, CA). The FDA issued a Cleared decision on May 29, 2014, 140 days after receiving the submission on January 9, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.
| 510(k) Number | K140049 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 09, 2014 |
| Decision Date | May 29, 2014 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTL — Ventilator, Emergency, Powered (resuscitator) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5925 |