Cleared Traditional

K963578 - PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)

K963578 is an FDA 510(k) clearance for PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG), manufactured by Intl. Products, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K963578 · Intl. Products, Inc. · Cardiovascular device
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Jun 1997
Decision
297d
Days
Class 2
Risk

K963578 is an FDA 510(k) clearance for the PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Intl. Products, Inc. (Vienna, US). The FDA issued a Cleared decision on June 30, 1997 after a review of 297 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 Intl. Products, Inc. devices

FDA 510(k) Submission Details - K963578

510(k) Number K963578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1996
Decision Date June 30, 1997
Days to Decision 297 days
Submission Type Traditional
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
172d slower than avg
Panel avg: 125d · This submission: 297d
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 403
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K963578.
NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH
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SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
K964784 · Quinton, Inc. · Aug 1997
POSEIDON CARDIAC MONITORING SYSTEM (PCMS)
K964408 · Instromedix, Inc. · Jul 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)
K970787 · Alexander Mfg. Co. · May 1997
PS-41 6M PATIENT SIMULATOR
K963198 · Metron U.S., Inc. · Mar 1997
NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER
K963400 · Nellcor Puritan Bennett, Inc. · Nov 1996