Cleared Traditional

K134035 - TRANSONIC HCM 103 SYSTEM
(FDA 510(k) Clearance)

K134035 · Transonic Systems, Inc. · Cardiovascular

Sep 2014

Decision

260d

Days

Class 2

Risk

K134035 is an FDA 510(k) clearance for the TRANSONIC HCM 103 SYSTEM, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on September 17, 2014, 260 days after receiving the submission on December 31, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number	K134035 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 31, 2013
Decision Date	September 17, 2014
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF