Cleared Traditional

K964784 - SYNERGY CARDIOLOGY INFORMATION SYSTEM (...

K964784 is the FDA 510(k) clearance for SYNERGY CARDIOLOGY INFORMATION SYSTEM (... by Quinton, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K964784 · Quinton, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
259d
Days
Class 2
Risk

K964784 is an FDA 510(k) clearance for the SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on August 13, 1997 after a review of 259 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Quinton, Inc. devices

Submission Details

510(k) Number K964784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1996
Decision Date August 13, 1997
Days to Decision 259 days
Submission Type Traditional
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
134d slower than avg
Panel avg: 125d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 265
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K964784.
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K972310 · Nihon Kohden America, Inc. · Aug 1997
POSEIDON CARDIAC MONITORING SYSTEM (PCMS)
K964408 · Instromedix, Inc. · Jul 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)
K970787 · Alexander Mfg. Co. · May 1997
NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER
K963400 · Nellcor Puritan Bennett, Inc. · Nov 1996