Cleared Traditional

K984504 - NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES (FDA 510(k) Clearance)

K984504 · Nihon Kohden America, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 1999
Decision
118d
Days
-
Risk

K984504 is an FDA 510(k) clearance for the NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on April 15, 1999 after a review of 118 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 K984504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1998
Decision Date April 15, 1999
Days to Decision 118 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -