Cleared Traditional

Smartdop XT6

K153762 · Koven Technology, Inc. · Cardiovascular
May 2016
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K153762 is an FDA 510(k) clearance for the Smartdop XT6, a Transducer, Ultrasonic (Class II — Special Controls, product code JOP), submitted by Koven Technology, Inc. (St Louis, US). The FDA issued a Cleared decision on May 25, 2016, 147 days after receiving the submission on December 30, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2880.

Submission Details

510(k) Number K153762 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2015
Decision Date May 25, 2016
Days to Decision 147 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