Cleared Traditional

AUREFLO MONITORING SYSTEM

K112657 · Transonic Systems, Inc. · Cardiovascular
Dec 2011
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K112657 is an FDA 510(k) clearance for the AUREFLO MONITORING SYSTEM, a Flowmeter, Blood, Cardiovascular (Class II — Special Controls, product code DPW), submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on December 21, 2011, 99 days after receiving the submission on September 13, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2100.

Submission Details

510(k) Number K112657 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2011
Decision Date December 21, 2011
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPW — Flowmeter, Blood, Cardiovascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2100

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