510(k) K081355 ยท ILY Lamp, Infrared, Therapeutic Heating
BIOFLEX LD-R100 TREATMENT HEAD
| Applicant | Meditech International, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Dec 18, 2008 |
| Received | May 14, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K081355
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.