Cleared Abbreviated

K032200 - ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH

K032200 is an FDA 510(k) clearance for ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH, manufactured by Remco Italia S.P.A.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Abbreviated 510(k) pathway after a 77-day FDA review.

K032200 · Remco Italia S.P.A. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
77d
Days
Class 2
Risk

K032200 is an FDA 510(k) clearance for the ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Remco Italia S.P.A. (Deer Field, US). The FDA issued a Cleared decision on October 3, 2003 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K032200

510(k) Number K032200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2003
Decision Date October 03, 2003
Days to Decision 77 days
Submission Type Abbreviated
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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Standards-based clearance path.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 572
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K032200.
CARDIOVIT AT-102
K031557 · Schiller AG · Apr 2004
HRV TOOLS
K040313 · Del Mar Reynolds Medical, Ltd. · Apr 2004
AUDICOR UPGRADE SYSTEM
K032145 · Inovise Medical, Inc. · Oct 2003
CARDIODIRECT, MODELS 12M, 12I, 12S
K024283 · Reynolds Medical , Ltd. · Aug 2003
ELI 200+ AUDICOR
K031182 · Mortara Instrument, Inc. · Jul 2003
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
K031422 · Philips Medical Systems · Jul 2003
K032200 · ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH
Download PDF FDA Summary Remco Italia S.P.A.