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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 141
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K083309.
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
K083903 · 3M Company · Jul 2009
SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM
K082528 · Noble Anesthesia-Air, Inc. · Mar 2009
PROTRON TECHNOLOGIES, LLC STETHOTRON
K082771 · Protron Technologies, LLC · Feb 2009
TR-USB TELEPHONIC STETHOSCOPE
K081032 · Rnk Products, Inc. · Jun 2008
AUSCO ES-3100
K070550 · Koratek Company, Ltd. · Nov 2007
RNK ELECTRONIC STETHOSCOPE
K072026 · Rnk Products, Inc. · Oct 2007
K083309 · ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33
Download PDF FDA Summary Zargis Medical Corp.