Submission Details
| 510(k) Number | K080533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2008 |
| Decision Date | August 11, 2008 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |