510(k) K942599 ยท DWJ System, Thermal Regulating
WARM AIR WARMING UNIT
| Applicant | Cincinnati Sub-Zero Products, Inc., Sharonville OH, US |
| Decision | Substantially Equivalent, Jan 24, 1995 |
| Received | Jun 1, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942599
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2010 | Cincinnati Sub-Zero Products Inc FilteredFlo Cardiac Blanket.
The device is used to distribute heated air around a patient (for patient warming). Terminated |
DWJ | None listed |
| Oct 29, 2009 | Cincinnati Sub-Zero Products Inc WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming
patients before, during and after su Terminated |
DWJ | None listed |
| Dec 30, 2004 | Cincinnati Sub-Zero Products Warm Air Model 135 Warming Units. Terminated |
BTE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.