Cleared Traditional

KENT CAMERA

K113507 · Kent Imaging, Inc. · Cardiovascular
Aug 2012
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K113507 is an FDA 510(k) clearance for the KENT CAMERA, a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Kent Imaging, Inc. (Calgary, CA). The FDA issued a Cleared decision on August 8, 2012, 254 days after receiving the submission on November 28, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K113507 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2011
Decision Date August 08, 2012
Days to Decision 254 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MUD — Oximeter, Tissue Saturation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700