510(k) K073712 ยท DWJ System, Thermal Regulating
SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100
| Applicant | Adroit Medical Systems, Inc., Loudon TN, US |
| Decision | Substantially Equivalent, Jun 6, 2008 |
| Received | Dec 31, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073712
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.