Cleared Traditional

K904032 - ELITE II ELECTROCARDIOGRAPH (FDA 510(k) Clearance)

K904032 · Burdick Corp. · Cardiovascular device
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Jul 1991
Decision
327d
Days
-
Risk

K904032 is an FDA 510(k) clearance for the ELITE II ELECTROCARDIOGRAPH.

Submitted by Burdick Corp. (Miltoon, US). The FDA issued a Cleared decision on July 24, 1991 after a review of 327 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 K904032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1990
Decision Date July 24, 1991
Days to Decision 327 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 125d · This submission: 327d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -