Cleared Traditional

WARMAIR SYSTEM

K910327 · Cincinnati Sub-Zero Products, Inc. · Cardiovascular

May 1991

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K910327 is an FDA 510(k) clearance for the WARMAIR SYSTEM, 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 May 16, 1991, 111 days after receiving the submission on January 25, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K910327 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 1991
Decision Date	May 16, 1991
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—

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).