Cleared Traditional

K003392 - CARDIO MONITOR CENTER VISION

Also marketed or referenced as:
MODEL S-CV7-00

K003392 is an FDA 510(k) clearance for CARDIO MONITOR CENTER VISION, manufactured by Shl Telemedicine International , Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K003392 · Shl Telemedicine International , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
86d
Days
Class 2
Risk

K003392 is an FDA 510(k) clearance for the CARDIO MONITOR CENTER VISION. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Shl Telemedicine International , Ltd. (Tel-Aviv, IL). The FDA issued a Cleared decision on January 25, 2001 after a review of 86 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shl Telemedicine International , Ltd. devices

FDA 510(k) Submission Details - K003392

510(k) Number K003392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2000
Decision Date January 25, 2001
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
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 327
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K003392.
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
PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
K002459 · Agilent Technologies, Inc. · Nov 2000
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
K002473 · Nihon Kohden America, Inc. · Nov 2000
QUINTON Q-STRESS, MODEL 000483
K001492 · Quinton, Inc. · Aug 2000