Cleared Traditional

K142173 - NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
(FDA 510(k) Clearance)

K142173 · Ecolab, Inc. · General Hospital

Dec 2014

Decision

145d

Days

Class 1

Risk

K142173 is an FDA 510(k) clearance for the NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE, a Warmer, Irrigation Solution (Class I — General Controls, product code LHC), submitted by Ecolab, Inc. (Saint Paul, US). The FDA issued a Cleared decision on December 30, 2014, 145 days after receiving the submission on August 7, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 890.5950.

Submission Details

510(k) Number	K142173 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 2014
Decision Date	December 30, 2014
Days to Decision	145 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF