Submission Details
| 510(k) Number | K110893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2011 |
| Decision Date | November 22, 2011 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |