510(k) K101705 ยท DWJ System, Thermal Regulating
MISTRAL-AIR WARMING SYSTEM
| Applicant | The Surgical Company International B.V., Beeldschermweg 6g, NL |
| Decision | Substantially Equivalent, Jul 2, 2010 |
| Received | Jun 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2017 | Stryker Medical Division of Stryker Corporation MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.