CARDIOVISION SOFTWARE, MODEL S-CV5-96— 510(k) K981807

Substantially Equivalent

Shl Telemedicine International , Ltd.

FDA 510(k) clearance K981807 for CARDIOVISION SOFTWARE, MODEL S-CV5-96, Substantially Equivalent on 1998-08-19. Applicant: Shl Telemedicine International , Ltd..

Clearance details

Applicant: Shl Telemedicine International , Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1998-05-21
Decision date: 1998-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel-Aviv, IL

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.