CONNECTED CARE MOBILE APPLICATION— 510(k) K120325

Substantially Equivalent

Watermark Medical

FDA 510(k) clearance K120325 for CONNECTED CARE MOBILE APPLICATION, Substantially Equivalent on 2012-07-18. Applicant: Watermark Medical.

Clearance details

Applicant: Watermark Medical
Product code: 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

Download summary PDF View on FDA.gov ↗

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.