510(k) K080908 ยท NCX System, Hypothermia, Intravenous, Cooling
INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
| Applicant | Innercool Therapies, Inc.- A Delaware Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 17, 2008 |
| Received | Apr 1, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080908
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2014 | Philips Healthcare InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V).
Product Usage:
The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hy Terminated |
NCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.