510(k) K101148 ยท DWJ System, Thermal Regulating
WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS
| Applicant | Cincinnati Sub-Zero Products, Inc., Sharonville OH, US |
| Decision | Substantially Equivalent, Oct 1, 2010 |
| Received | Apr 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101148
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2011 | Cincinnati Sub-Zero Products Inc Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Terminated |
DWJ | None listed |
| Jul 27, 2011 | Cincinnati Sub-Zero Products Inc WarmAir Model 135 Convective Warming Device,
Cincinnati Sub-Zero Products, Inc.
Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convec Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.