Cleared Traditional

K042145 - READY-HEAT BLANKET
(FDA 510(k) Clearance)

K042145 · Techtrade, LLC · General Hospital

Sep 2004

Decision

39d

Days

Class 1

Risk

K042145 is an FDA 510(k) clearance for the READY-HEAT BLANKET. This device is classified as a Bedding, Disposable, Medical (Class I - General Controls, product code KME).

Submitted by Techtrade, LLC (Potomac, US). The FDA issued a Cleared decision on September 17, 2004, 39 days after receiving the submission on August 9, 2004.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6060.

Submission Details

510(k) Number	K042145 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 09, 2004
Decision Date	September 17, 2004
Days to Decision	39 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement