Cleared Traditional

K960449 - PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)

K960449 is an FDA 510(k) clearance for PC ECG 1200 ECG AND STRESS ELECTROCARDI..., manufactured by Biosensor Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K960449 · Biosensor Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
121d
Days
Class 2
Risk

K960449 is an FDA 510(k) clearance for the PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Biosensor Corp. (Minneapolis, US). The FDA issued a Cleared decision on May 30, 1996 after a review of 121 days - within the typical 510(k) review window.

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 Biosensor Corp. devices

FDA 510(k) Submission Details - K960449

510(k) Number K960449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1996
Decision Date May 30, 1996
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
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 334
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K960449.
DINAMAP SELECT MULTI-PARAMETER SYSTEM
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K955642 · Nellcor Puritan Bennett, Inc. · Jul 1996
CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM
K950018 · Cambridge Heart, Inc. · Feb 1996
6200 VITAL SIGNS MONITOR
K953415 · Bci Intl., Inc. · Oct 1995
HEWLETT-PACKARD MODEL M1264B CATHSTATION
K952173 · Hewlett-Packard Co. · Aug 1995