Cleared Traditional

TRANSONIC HCM 102 SYSTEM

K140017 · Transonic Systems, Inc. · Cardiovascular
Sep 2014
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K140017 is an FDA 510(k) clearance for the TRANSONIC HCM 102 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 16, 2014, 257 days after receiving the submission on January 2, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number K140017 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2014
Decision Date September 16, 2014
Days to Decision 257 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXG — Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1435

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