Cleared Traditional

SERIES 1500 12-LEAD ANALYSIS OPTION (K903644) - FDA 510(k) Clearance

K903644 · Marquette Electronics, Inc. · Cardiovascular device
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Dec 1991
Decision
501d
Days
-
Risk

K903644 is an FDA 510(k) clearance for the SERIES 1500 12-LEAD ANALYSIS OPTION.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 27, 1991 after a review of 501 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Marquette Electronics, Inc. devices

Submission Details

510(k) Number K903644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1990
Decision Date December 27, 1991
Days to Decision 501 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
376d slower than avg
Panel avg: 125d · This submission: 501d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 15
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