Cleared Traditional

TRANSONIC ELSA SYSTEM

K134051 · Transonic Systems, Inc. · Cardiovascular
Jan 2015
Decision
394d
Days
Class 2
Risk

About This 510(k) Submission

K134051 is an FDA 510(k) clearance for the TRANSONIC ELSA 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 January 29, 2015, 394 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 K134051 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2013
Decision Date January 29, 2015
Days to Decision 394 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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