Cleared Traditional

HIGH RESOLUTION OPTION FOR MAC SERIES ELECTROCARDI (K884087) - 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.

View all Marquette Electronics, Inc. devices

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 -

Regulatory Peers - LOS

All 15
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N-CHANNEL
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