K120325

Substantially Equivalent

CONNECTED CARE MOBILE APPLICATION

Applicant: Watermark Medical
Product code: DRG
Advisory panel: Cardiovascular
Date received: 2012-02-02
Decision date: 2012-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookfield, WI, 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.