FDA 510(k) Applications Submitted by MEDIVANCE, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200225 |
01/30/2020 |
Arctic Sun Stat Temperature Management System |
Medivance, Inc. |
| K243942 |
12/20/2024 |
Arctic Sun Stat Temperature Management System |
Medivance, Inc. |
| K010338 |
02/05/2001 |
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 |
MEDIVANCE, INC. |
| K120849 |
03/20/2012 |
HYBRID ARCTICGEL PAD |
MEDIVANCE, INC. |
| K080899 |
03/31/2008 |
ARCTIC BLAST INTRAVENOUS FLUID CHILLER |
MEDIVANCE, INC. |
| K110956 |
04/05/2011 |
MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR |
MEDIVANCE, INC. |
| K101092 |
04/20/2010 |
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 |
MEDIVANCE, INC. |
| K071341 |
05/14/2007 |
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 |
MEDIVANCE, INC. |
| K002577 |
08/18/2000 |
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS |
MEDIVANCE, INC. |
| K161602 |
06/09/2016 |
Arctic Sun Temperature Management System |
Medivance, Inc. |
| K142702 |
09/22/2014 |
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad |
MEDIVANCE, INC. |
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