Cleared Traditional

SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

K070795 · Atcor Medical Pty, Ltd. · Cardiovascular

Aug 2007

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K070795 is an FDA 510(k) clearance for the SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM, a Computer, Blood-pressure (Class II — Special Controls, product code DSK), submitted by Atcor Medical Pty, Ltd. (Washington, D.C., US). The FDA issued a Cleared decision on August 31, 2007, 162 days after receiving the submission on March 22, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1110.

Submission Details

510(k) Number	K070795 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2007
Decision Date	August 31, 2007
Days to Decision	162 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF