Cleared Special

K071341 - MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
(FDA 510(k) Clearance)

K071341 · Medivance, Inc. · Cardiovascular

Aug 2007

Decision

81d

Days

Class 2

Risk

K071341 is an FDA 510(k) clearance for the MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Medivance, Inc. (Louisville, US). The FDA issued a Cleared decision on August 3, 2007, 81 days after receiving the submission on May 14, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K071341 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2007
Decision Date	August 03, 2007
Days to Decision	81 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWJ — System, Thermal Regulating
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5900
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).