Cleared Traditional

DEFIBRILLATOR ANALYZER - DA-2006P

K110192 · Bc Group International, Inc. · Cardiovascular
Feb 2011
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K110192 is an FDA 510(k) clearance for the DEFIBRILLATOR ANALYZER - DA-2006P, a Tester, Defibrillator (Class II — Special Controls, product code DRL), submitted by Bc Group International, Inc. (Oak Grove, US). The FDA issued a Cleared decision on February 8, 2011, 15 days after receiving the submission on January 24, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5325.

Submission Details

510(k) Number K110192 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2011
Decision Date February 08, 2011
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRL — Tester, Defibrillator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5325