Cleared Traditional

IOB Temperature Management System

K162679 · Iob Medical, Inc. · Cardiovascular

Apr 2017

Decision

214d

Days

Class 2

Risk

About This 510(k) Submission

K162679 is an FDA 510(k) clearance for the IOB Temperature Management System, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Iob Medical, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on April 28, 2017, 214 days after receiving the submission on September 26, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K162679 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2016
Decision Date	April 28, 2017
Days to Decision	214 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).