Cleared Special

K083309 - ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33

K083309 is an FDA 510(k) clearance for ZARGIS ACOUSTIC CARDIOSCAN, manufactured by Zargis Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Special 510(k) pathway after a 95-day FDA review.

K083309 · Zargis Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
95d
Days
Class 2
Risk

K083309 is an FDA 510(k) clearance for the ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Zargis Medical Corp. (Princeton, US). The FDA issued a Cleared decision on February 13, 2009 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - the FDA cardiovascular device oversight framework. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zargis Medical Corp. devices

FDA 510(k) Submission Details - K083309

510(k) Number K083309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2008
Decision Date February 13, 2009
Days to Decision 95 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Modification to existing cleared device.

DQD Device Classification - Class 2, Special Controls

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQD Stethoscope, Electronic

All 63
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