Cleared Special

K083749 - CARDIOVIEW32 REVIEW MODULE

K083749 · Qrs Diagnostic, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
83d
Days
-
Risk

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 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K083749

510(k) Number K083749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 70
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K083749 · CARDIOVIEW32 REVIEW MODULE
Download PDF FDA Summary Qrs Diagnostic, LLC