Cleared Special

MEDGRAPHICS ULTIMA SYSTEM

K061731 · Medical Graphics Corp. · Anesthesiology

Sep 2006

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K061731 is an FDA 510(k) clearance for the MEDGRAPHICS ULTIMA SYSTEM, 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 September 6, 2006, 78 days after receiving the submission on June 20, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1730.

Submission Details

510(k) Number	K061731 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2006
Decision Date	September 06, 2006
Days to Decision	78 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF