Cleared Traditional

COCOON CONVECTIVE WARMING SYSTEM

K140635 · Care Essentials Pty, Ltd. · Cardiovascular

Jul 2014

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K140635 is an FDA 510(k) clearance for the COCOON CONVECTIVE WARMING SYSTEM, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Care Essentials Pty, Ltd. (Parkside, South Australia, AU). The FDA issued a Cleared decision on July 25, 2014, 135 days after receiving the submission on March 12, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K140635 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 12, 2014
Decision Date	July 25, 2014
Days to Decision	135 days
Submission Type	Traditional
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).