Cleared Special

MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

K080670 · Atcor Medical · Cardiovascular

Apr 2008

Decision

44d

Days

Class 2

Risk

About This 510(k) Submission

K080670 is an FDA 510(k) clearance for the MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM, a Computer, Blood-pressure (Class II — Special Controls, product code DSK), submitted by Atcor Medical (West Ryde Nsw, AU). The FDA issued a Cleared decision on April 23, 2008, 44 days after receiving the submission on March 10, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1110.

Submission Details

510(k) Number	K080670 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2008
Decision Date	April 23, 2008
Days to Decision	44 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF