DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Lifewatch Services, Inc.
Product code
Code QYX
Device class
Class 2
Regulation
21 CFR 870.1025
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rosemont, IL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code QYX

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Adverse events under product code QYX

product code QYX
Death
13
Malfunction
526
Total
539

Source: openFDA MAUDE database, through . 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.