Cleared Traditional

K884087 - HIGH RESOLUTION OPTION FOR MAC SERIES ELECTROCARDI (FDA 510(k) Clearance)

K884087 · Marquette Electronics, Inc. · Cardiovascular device
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Feb 1989
Decision
149d
Days
-
Risk

K884087 is an FDA 510(k) clearance for the HIGH RESOLUTION OPTION FOR MAC SERIES ELECTROCARDI.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 149 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.

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Submission Details

510(k) Number K884087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1988
Decision Date February 23, 1989
Days to Decision 149 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 125d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -