LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L— 510(k) K170565

Substantially Equivalent

Lifewatch Services, Inc.

FDA 510(k) clearance K170565 for LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L, Substantially Equivalent on 2017-08-01. Applicant: Lifewatch Services, Inc..

Clearance details

Applicant: Lifewatch Services, Inc.
Product code: Code QYX
Advisory panel: Cardiovascular
Date received: 2017-02-27
Decision date: 2017-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosemont, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QYX

product code QYX

Death: 13
Malfunction: 526
Total: 539

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.