Cleared Traditional

Kent Camera

K163070 · Kent Imaging, Inc. · Cardiovascular
May 2017
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K163070 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 May 5, 2017, 184 days after receiving the submission on November 2, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K163070 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2016
Decision Date May 05, 2017
Days to Decision 184 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