Cleared Traditional

K820885 - MARQUETTE OPTION II ECG ANALYSIS COMPUT (FDA 510(k) Clearance)

K820885 · Marquette Electronics, Inc. · Cardiovascular device
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Apr 1982
Decision
16d
Days
-
Risk

K820885 is an FDA 510(k) clearance for the MARQUETTE OPTION II ECG ANALYSIS COMPUT.

Submitted by Marquette Electronics, Inc. (Walker, US). The FDA issued a Cleared decision on April 15, 1982 after a review of 16 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marquette Electronics, Inc. devices

Submission Details

510(k) Number K820885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1982
Decision Date April 15, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -