WVSM (WIRLESS VITAL SIGNS MONITOR)— 510(k) K130957

Substantially Equivalent

Athena Gtx

FDA 510(k) clearance K130957 for WVSM (WIRLESS VITAL SIGNS MONITOR), Substantially Equivalent on 2013-04-30. Applicant: Athena Gtx.

Clearance details

Applicant: Athena Gtx
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2013-04-05
Decision date: 2013-04-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Des Moines, IA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.