Cleared Traditional

K884800 - ACTA GENOS ELECTROCARDIOGRAPH

K884800 is an FDA 510(k) clearance for ACTA GENOS ELECTROCARDIOGRAPH, manufactured by Parexel Intl. Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K884800 · Parexel Intl. Corp. · Cardiovascular device
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Jun 1989
Decision
218d
Days
Class 2
Risk

K884800 is an FDA 510(k) clearance for the ACTA GENOS ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Parexel Intl. Corp. (Cambridge, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 218 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. 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 Parexel Intl. Corp. devices

FDA 510(k) Submission Details - K884800

510(k) Number K884800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1988
Decision Date June 22, 1989
Days to Decision 218 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 125d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 446
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K884800.
KONTRON KOLORMON 7250 PATIENT MONITOR
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K893660 · Bio-Tek Instruments, Inc. · Dec 1989
CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512
K890875 · Ppg Industries, Inc. · Oct 1989
E350 ELECTROCARDIOGRAPH
K892835 · Burdick Corp. · Jun 1989
TYPE 9040 SYSTEM ATHENA
K884116 · S & W Medico Teknik · Apr 1989
7610 COLORVIEW SLAVE SCOPE
K890481 · Marquette Electronics, Inc. · Mar 1989