Cleared Traditional

EKG-PLUS II SOFTWARE

K090895 · Bionet Co., Ltd. · Cardiovascular
Aug 2009
Decision
149d
Days
—
Risk

About This 510(k) Submission

K090895 is an FDA 510(k) clearance for the EKG-PLUS II SOFTWARE, submitted by Bionet Co., Ltd. (-Gu, Seoul, KR). The FDA issued a Cleared decision on August 26, 2009, 149 days after receiving the submission on March 30, 2009. This device falls under the Cardiovascular review panel.

Submission Details

510(k) Number K090895 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2009
Decision Date August 26, 2009
Days to Decision 149 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LOS
Device Class —