Cleared Traditional

K981024 - QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM) (FDA 510(k) Clearance)

K981024 · Marquette Medical Systems, Inc. · Cardiovascular device
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Oct 1998
Decision
201d
Days
-
Risk

K981024 is an FDA 510(k) clearance for the QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM).

Submitted by Marquette Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 6, 1998 after a review of 201 days - an extended review cycle.

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 Marquette Medical Systems, Inc. devices

Submission Details

510(k) Number K981024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1998
Decision Date October 06, 1998
Days to Decision 201 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 125d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -