Cleared Traditional

NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS

K120081 · Cincinnati Sub-Zero Products, Inc. · Cardiovascular

Feb 2012

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K120081 is an FDA 510(k) clearance for the NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Cincinnati Sub-Zero Products, Inc. (Sharonville, US). The FDA issued a Cleared decision on February 17, 2012, 37 days after receiving the submission on January 11, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K120081 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 2012
Decision Date	February 17, 2012
Days to Decision	37 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).