Cleared Traditional

E560 ELECTROCARDIOGRAPH (K903565) - FDA 510(k) Clearance

K903565 · Burdick Corp. · Cardiovascular device
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Jul 1991
Decision
351d
Days
-
Risk

K903565 is an FDA 510(k) clearance for the E560 ELECTROCARDIOGRAPH.

Submitted by Burdick Corp. (Miltoon, US). The FDA issued a Cleared decision on July 24, 1991 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Corp. devices

Submission Details

510(k) Number K903565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1990
Decision Date July 24, 1991
Days to Decision 351 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 125d · This submission: 351d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 15
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K903565.
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
PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A
K895520 · Hewlett-Packard Co. · Jul 1990
Q750 ELECTROCARDIOGRAPH
K885000 · Quinton, Inc. · Feb 1989
MINGOGRAF 740 - MODEL #91-54-634
K864575 · Siemens Medical Solutions USA, Inc. · May 1987