Cleared Traditional

TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM

K080116 · Transonic Systems, Inc. · Cardiovascular
Sep 2008
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K080116 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 8, 2008, 236 days after receiving the submission on January 16, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number K080116 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2008
Decision Date September 08, 2008
Days to Decision 236 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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