BodyGuardian Remote Monitoring System— 510(k) K151188

Substantially Equivalent

Preventice

FDA 510(k) clearance K151188 for BodyGuardian Remote Monitoring System, Substantially Equivalent on 2015-09-17. Applicant: Preventice.

Clearance details

Applicant: Preventice
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2015-05-04
Decision date: 2015-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MN, 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.