Cleared Traditional

SMARTDOP XT

K131623 · Koven Technology, Inc. · Cardiovascular
Jan 2014
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K131623 is an FDA 510(k) clearance for the SMARTDOP XT, a Transducer, Ultrasonic (Class II — Special Controls, product code JOP), submitted by Koven Technology, Inc. (Houston, US). The FDA issued a Cleared decision on January 17, 2014, 227 days after receiving the submission on June 4, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2880.

Submission Details

510(k) Number K131623 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2013
Decision Date January 17, 2014
Days to Decision 227 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOP — Transducer, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2880