V-PATCH SYSTEM— 510(k) K131000

Substantially Equivalent

Intelesens Limited

FDA 510(k) clearance K131000 for V-PATCH SYSTEM, Substantially Equivalent on 2014-01-08. Applicant: Intelesens Limited.

Clearance details

Applicant: Intelesens Limited
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2013-04-10
Decision date: 2014-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

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.