K080899 is an FDA 510(k) clearance for the ARCTIC BLAST INTRAVENOUS FLUID CHILLER. This device is classified as a System, Hypothermia, Intravenous, Cooling (Class II - Special Controls, product code NCX).
Submitted by Medivance, Inc. (Louisville, US). The FDA issued a Cleared decision on August 7, 2008, 129 days after receiving the submission on March 31, 2008.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.5900.
| 510(k) Number | K080899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2008 |
| Decision Date | August 07, 2008 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NCX - System, Hypothermia, Intravenous, Cooling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5900 |