Cleared Traditional

SPACELABS HEALTHCARE CARDIOEXPRESS

K130207 · Spacelabs Healthcare, Ltd. · Cardiovascular
Jul 2013
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K130207 is an FDA 510(k) clearance for the SPACELABS HEALTHCARE CARDIOEXPRESS, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Spacelabs Healthcare, Ltd. (Nederland, US). The FDA issued a Cleared decision on July 23, 2013, 176 days after receiving the submission on January 28, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K130207 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2013
Decision Date July 23, 2013
Days to Decision 176 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