Cleared Traditional

WARM AIR WARMING UNIT

K942599 · Cincinnati Sub-Zero Products, Inc. · Cardiovascular

Jan 1995

Decision

237d

Days

Class 2

Risk

About This 510(k) Submission

K942599 is an FDA 510(k) clearance for the WARM AIR WARMING UNIT, 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 January 24, 1995, 237 days after receiving the submission on June 1, 1994. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K942599 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 1994
Decision Date	January 24, 1995
Days to Decision	237 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).