510(k) K040632 ยท DWJ System, Thermal Regulating
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
| Applicant | Smiths Medical Asd, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Apr 27, 2004 |
| Received | Mar 10, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040632
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2014 | Smiths Medical ASD, Inc. SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hyp Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.