Cleared Traditional

EDAC QUANTIFIER

K071231 · Luna Innovations, Inc. · Cardiovascular

May 2007

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K071231 is an FDA 510(k) clearance for the EDAC QUANTIFIER, a Detector, Bubble, Cardiopulmonary Bypass (Class II — Special Controls, product code KRL), submitted by Luna Innovations, Inc. (Blacksburg, US). The FDA issued a Cleared decision on May 17, 2007, 14 days after receiving the submission on May 3, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4205.

Submission Details

510(k) Number	K071231 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2007
Decision Date	May 17, 2007
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF