Cleared Traditional

TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM

K113821 · Transonic Systems, Inc. · Cardiovascular
Sep 2012
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K113821 is an FDA 510(k) clearance for the TRANSONIC COSTATUS CARDIAC OUTPUT 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 7, 2012, 255 days after receiving the submission on December 27, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number K113821 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2011
Decision Date September 07, 2012
Days to Decision 255 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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