Cleared Special

CARDIOVIEW32 REVIEW MODULE

K083749 · Qrs Diagnostic, LLC · Cardiovascular
Mar 2009
Decision
83d
Days
—
Risk

About This 510(k) Submission

K083749 is an FDA 510(k) clearance for the CARDIOVIEW32 REVIEW MODULE, submitted by Qrs Diagnostic, LLC (Plymouth, US). The FDA issued a Cleared decision on March 10, 2009, 83 days after receiving the submission on December 17, 2008. This device falls under the Cardiovascular review panel.

Submission Details

510(k) Number K083749 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2008
Decision Date March 10, 2009
Days to Decision 83 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LOS
Device Class —