510(k) K132803— MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK

Substantially Equivalent

Medapps Inc., Dba Alere Connect

Clearance details

Applicant: Medapps Inc., Dba Alere Connect
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2013-09-06
Decision date: 2013-12-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Scottsdale, AZ, US

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.