Cleared Traditional

ARCTIC BLAST INTRAVENOUS FLUID CHILLER

K080899 · Medivance, Inc. · Neurology
Aug 2008
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K080899 is an FDA 510(k) clearance for the ARCTIC BLAST INTRAVENOUS FLUID CHILLER, 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 review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number K080899 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NCX — System, Hypothermia, Intravenous, Cooling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5900

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