Cleared Traditional

CARECENTER MD

K093211 · Cardiac Science Corporation · Cardiovascular
Jun 2010
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K093211 is an FDA 510(k) clearance for the CARECENTER MD, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Cardiac Science Corporation (Bothell, US). The FDA issued a Cleared decision on June 3, 2010, 233 days after receiving the submission on October 13, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K093211 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2009
Decision Date June 03, 2010
Days to Decision 233 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340