Cleared Special

K060197 - ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28

K060197 is an FDA 510(k) clearance for ZARGIS ACOUSTIC CARDIOSCAN (ZAC), 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 62-day FDA review.

K060197 · Zargis Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
62d
Days
Class 2
Risk

K060197 is an FDA 510(k) clearance for the ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28. 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 March 29, 2006 after a review of 62 days - a notably fast clearance cycle.

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. 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 - K060197

510(k) Number K060197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2006
Decision Date March 29, 2006
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
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 K060197.
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K060321 · American Diagnostic Corp. · May 2006
HEART STG SYSTEM AND SOFTWARE
K052283 · Stethographics, Inc. · Dec 2005
EXTENDED MEASUREMENTS SYSTEM
K051450 · Inovise Medical, Inc. · Nov 2005
TECHNO-SCOPE VISUAL STETHOSCOPE
K050097 · Techtrade, LLC · Sep 2005
K060197 · ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28
Download PDF FDA Summary Zargis Medical Corp.