Cleared Traditional

K062099 - PHASE 3, MODEL DT-1
(FDA 510(k) Clearance)

K062099 · Datrend Systems, Inc. · Cardiovascular
Jan 2007
Decision
185d
Days
Class 2
Risk

K062099 is an FDA 510(k) clearance for the PHASE 3, MODEL DT-1. This device is classified as a Tester, Defibrillator (Class II — Special Controls, product code DRL).

Submitted by Datrend Systems, Inc. (Richmond, British Columbia, CA). The FDA issued a Cleared decision on January 25, 2007, 185 days after receiving the submission on July 24, 2006.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5325.

Submission Details

510(k) Number K062099 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2006
Decision Date January 25, 2007
Days to Decision 185 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