Cleared Traditional

THERMAL REGULATION SYSTEM BLANKET

K964377 · Gibeck, Inc. · Cardiovascular

Apr 1997

Decision

173d

Days

Class 2

Risk

About This 510(k) Submission

K964377 is an FDA 510(k) clearance for the THERMAL REGULATION SYSTEM BLANKET, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Gibeck, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 23, 1997, 173 days after receiving the submission on November 1, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K964377 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 1996
Decision Date	April 23, 1997
Days to Decision	173 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement

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).