Cleared Traditional

IMPULSE 6000D/7000DP

K072114 · Fluke Biomedical · Cardiovascular
Jan 2008
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K072114 is an FDA 510(k) clearance for the IMPULSE 6000D/7000DP, a Tester, Defibrillator (Class II — Special Controls, product code DRL), submitted by Fluke Biomedical (Orange, US). The FDA issued a Cleared decision on January 28, 2008, 180 days after receiving the submission on August 1, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5325.

Submission Details

510(k) Number K072114 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2007
Decision Date January 28, 2008
Days to Decision 180 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