Cleared Traditional

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

K984504 · Nihon Kohden America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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.

View all Nihon Kohden America, Inc. devices

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
Combination Product No
PCCP Authorized No
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 -

Regulatory Peers - LOS

All 14
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K984504.
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K961014 · Quinton, Inc. · Jul 1996
PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO
K954980 · Hewlett-Packard Co. · May 1996