LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream— 510(k) K153719

Substantially Equivalent

Honeywell Hommed, LLC

FDA 510(k) clearance K153719 for LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream, Substantially Equivalent on 2016-06-03. Applicant: Honeywell Hommed, LLC.

Clearance details

Applicant
Honeywell Hommed, LLC
Product code
Code DRG
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brookfield, WI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DRG

product code DRG
Death
5
Total
5

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.