Cleared Abbreviated

K020708 - PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES

K020708 is an FDA 510(k) clearance for PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Abbreviated 510(k) pathway after a 51-day FDA review.

K020708 · Philips Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
51d
Days
Class 2
Risk

K020708 is an FDA 510(k) clearance for the PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (Andover, US). The FDA issued a Cleared decision on April 25, 2002 after a review of 51 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.

View all Philips Medical Systems, Inc. devices

FDA 510(k) Submission Details - K020708

510(k) Number K020708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2002
Decision Date April 25, 2002
Days to Decision 51 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Entela, Inc.
N.E. DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DPS Electrocardiograph

All 418
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K020708.
X-SCRIBE II
K022618 · Mortara Instrument, Inc. · Sep 2002
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K022149 · Cambridge Heart, Inc. · Jul 2002
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K022152 · Cambridge Heart, Inc. · Jul 2002
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K013564 · Cambridge Heart, Inc. · Nov 2001
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K013565 · Cambridge Heart, Inc. · Nov 2001
HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
K010758 · Cambridge Heart, Inc. · Apr 2001