The following data is part of a premarket notification filed by Medivance, Inc. with the FDA for Arctic Blast Intravenous Fluid Chiller.
| Device ID | K080899 |
| 510k Number | K080899 |
| Device Name: | ARCTIC BLAST INTRAVENOUS FLUID CHILLER |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | MEDIVANCE, INC. 1172 CENTURY DR., SUITE 240 Louisville, CO 80027 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson MEDIVANCE, INC. 1172 CENTURY DR., SUITE 240 Louisville, CO 80027 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-08-07 |
| Summary: | summary |