510(k) K140635 ยท DWJ System, Thermal Regulating
COCOON CONVECTIVE WARMING SYSTEM
| Applicant | Care Essentials Pty, Ltd., Parkside, South Australia, AU |
| Decision | Substantially Equivalent, Jul 25, 2014 |
| Received | Mar 12, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140635
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2020 | Care Essentials Pty., Ltd. Cocoon Convective Warming System, Product Code: CWS4000 (110V). Terminated |
DWJ | None listed |
| Jan 7, 2020 | Care Essentials Pty., Ltd. Cocoon Convective Warming System, Product Code: CWS5000 (110V). Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.