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Cardiovision Software, Model S-CV5-96

FDA 510(k)

Class II (US FDA 510(k))

510(k) K981807

by Shl Telemedicine International Ltd.

Identifiers

510(k) Number
K981807 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Cardiovision Software, Model S-CV5-96 is ECG display and storage software. It is classified under the product code DPS and was determined to be substantially equivalent to a predicate device through a traditional 510(k) clearance process.

The software was cleared by the FDA under 510(k) number K981807 on August 19, 1998. It is manufactured by Shl Telemedicine International Ltd. and is intended for use in cardiovascular applications as indicated by the advisory committee classification.

Frequently asked questions

What is Cardiovision Software, Model S-CV5-96 used for?

Cardiovision Software, Model S-CV5-96 is ECG display and storage software intended for use in cardiovascular applications, as indicated by its advisory committee classification and product code DPS.

How was Cardiovision Software, Model S-CV5-96 cleared for market?

The software was determined to be substantially equivalent to a predicate device through a traditional 510(k) clearance process, resulting in FDA clearance under K981807 on August 19, 1998.

Who manufactures Cardiovision Software, Model S-CV5-96 and where is it located?

Cardiovision Software, Model S-CV5-96 is manufactured by Shl Telemedicine International Ltd., located at 90 Yigal Alon St., Tel-Aviv, Israel, with postal code 67891.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CARDIOVISION SOFTWARE, MODEL S-CV5-96 - Innolitics, Shl Telemedicine International , Ltd. FDA 510(k) Products (1998-2012), FDA 510 (k) Applications Submitted by SHL TELEMEDICINE INTERNATIONAL LTD., PDF K981807 - Cardiovision Software, Model S-cv5-96, Device Listing 1533326481 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shl Telemedicine International Ltd.
FDA Applicant
Shl Telemedicine International , Ltd.

Sources (1)

  • FDA 510(k) K981807 24 fields · synced Oct 1, 2026