Cleared Special

WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS

K123946 · Cincinnati Sub-Zero Products, Inc. · Cardiovascular

Jan 2013

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K123946 is an FDA 510(k) clearance for the WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Cincinnati Sub-Zero Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 17, 2013, 27 days after receiving the submission on December 21, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K123946 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2012
Decision Date	January 17, 2013
Days to Decision	27 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).