Cleared Traditional

K943959 - ECLIPSE 4 ELECTROCARDIOGRAPH

K943959 · Burdick, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
275d
Days
-
Risk

K943959 is an FDA 510(k) clearance for the ECLIPSE 4 ELECTROCARDIOGRAPH.

Submitted by Burdick, Inc. (Miltoon, US). The FDA issued a Cleared decision on May 17, 1995 after a review of 275 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.

View all Burdick, Inc. devices

FDA 510(k) Submission Details - K943959

510(k) Number K943959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1994
Decision Date May 17, 1995
Days to Decision 275 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
150d slower than avg
Panel avg: 125d · This submission: 275d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 60
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CARDIOFAX Q ECG-8420A
K922394 · Nihon Kohden America, Inc. · Mar 1994