Cleared Special

EXPRESS SERIES

K070858 · Medical Graphics Corp. · Anesthesiology
Apr 2007
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K070858 is an FDA 510(k) clearance for the EXPRESS SERIES, a Computer, Oxygen-uptake (Class II — Special Controls, product code BZL), submitted by Medical Graphics Corp. (St. Paul, US). The FDA issued a Cleared decision on April 16, 2007, 19 days after receiving the submission on March 28, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1730.

Submission Details

510(k) Number K070858 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2007
Decision Date April 16, 2007
Days to Decision 19 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZL — Computer, Oxygen-uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1730