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

Submission Details

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.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 26
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K943959.
HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE PREDICITIVE INSTRUMENT (ACI-TIPT)
K951978 · Hewlett-Packard Co. · Jan 1996
CENTRA HEART STATION
K935589 · Marquette Electronics, Inc. · Aug 1995
ECG FAX MODEM
K941282 · Hewlett-Packard Co. · May 1995
HP M177XA CARDIOGRAPHS
K935772 · Hewlett-Packard Co. · Jul 1994
CARDIOFAX Q ECG-8420A
K922394 · Nihon Kohden America, Inc. · Mar 1994
MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITION
K921669 · Marquette Electronics, Inc. · May 1993