Cleared Traditional

K832092 - ELECTROCARDIOGRAPH MACHINES, W/ANALYZ (FDA 510(k) Clearance)

K832092 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Jan 1984
Decision
190d
Days
-
Risk

K832092 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPH MACHINES, W/ANALYZ.

Submitted by Fukuda Denshi USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 190 days - an extended review 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: 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 K832092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1983
Decision Date January 03, 1984
Days to Decision 190 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 125d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -