SmartLinx Vitals Plus Patient Monitoring System— 510(k) K183638

Substantially Equivalent

Capsule Technologie

FDA 510(k) clearance K183638 for SmartLinx Vitals Plus Patient Monitoring System, Substantially Equivalent on 2019-04-17. Applicant: Capsule Technologie.

Clearance details

Applicant: Capsule Technologie
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2018-12-26
Decision date: 2019-04-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.