VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)— 510(k) K132407

Substantially Equivalent

Lifewatch Technologies , Ltd.

FDA 510(k) clearance K132407 for VITAL SIGNS PATCH SYSTEM (IN SHORT VSP), Substantially Equivalent on 2014-12-19. Applicant: Lifewatch Technologies , Ltd..

Clearance details

Applicant: Lifewatch Technologies , Ltd.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2013-08-02
Decision date: 2014-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.