510(k) K100320 ยท NGX Stimulator, Muscle, Powered, For Muscle Conditioning
SLENDERTONE SYSTEM ULTRA MODEL E70/X70
| Applicant | Bio-Medical Research, Ltd., Galway, IE |
| Decision | Substantially Equivalent, May 5, 2010 |
| Received | Feb 4, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100320
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.