Cleared Traditional

QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH (K961014) - FDA 510(k) Clearance

K961014 · Quinton, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
140d
Days
-
Risk

K961014 is an FDA 510(k) clearance for the QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH.

Submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on July 31, 1996 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. 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 K961014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1996
Decision Date July 31, 1996
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 14
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K961014.
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K981265 · Hewlett-Packard Co. · Jun 1998
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT
K974087 · Hewlett-Packard Co. · Jun 1998
NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
K961272 · Nihon Kohden America, Inc. · Nov 1996
PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO
K954980 · Hewlett-Packard Co. · May 1996
HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE PREDICITIVE INSTRUMENT (ACI-TIPT)
K951978 · Hewlett-Packard Co. · Jan 1996
ECG FAX MODEM
K941282 · Hewlett-Packard Co. · May 1995