Cleared Traditional

K981807 - CARDIOVISION SOFTWARE, MODEL S-CV5-96

K981807 is an FDA 510(k) clearance for CARDIOVISION SOFTWARE, 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 90-day FDA review.

K981807 · Shl Telemedicine International , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
90d
Days
Class 2
Risk

K981807 is an FDA 510(k) clearance for the CARDIOVISION SOFTWARE, MODEL S-CV5-96. 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 August 19, 1998 after a review of 90 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 Shl Telemedicine International , Ltd. devices

FDA 510(k) Submission Details - K981807

510(k) Number K981807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1998
Decision Date August 19, 1998
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K981807.
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ANS 2000 ECG MONITOR AND RESPIRATION PACER
K973426 · D. E. Hokanson, Inc. · Aug 1998
M1765A ECG MANAGER
K974746 · Hewlett-Packard Co. · Mar 1998
FORMULA FOR ARCHIMED
K974079 · Biosound Esaote, Inc. · Jan 1998